Medical Device Recall Listings - Sorted by Manufacturer

(From July 2005 - September 2005)

Manufacturer

3M Health Care

Recall Posting Date

2005-09-05

Trade Name

3M Microfoam Surgical Tape

Recall Start Date

2005-08-08

Recall Number

28764

Hazard Classification

Type III

Model or Catalog #

1528-1, 1528-2, 1528-3, 1528-4

Lot or Serial #

2010-06 (HE, HR, HS, HU, IM, IN)

Reason for Recall

The tape may not perform as intended in some situations as portions of the tape may not appear to have adhesive or the adhesive may separate from the foam backing.

Manufacturer

Abbott Laboratories

Recall Posting Date

2005-09-05

Trade Name

A) Plum A+ Infusion Pumps

B) Plum A+3 Infusion Pumps

Recall Start Date

2005-06-02

Recall Number

28438

Hazard Classification

Type I

Model or Catalog #

A) N/A

B) N/A

Lot or Serial #

A) Numerus lot numbers.
B) Numerus lot numbers.

Reason for Recall

If battery service warning and E320 messages are not responded to appropriately, the pump may shut off during battery operation without providing adequate response time.

Manufacturer

Abbott Laboratories Diagnostic Division

Recall Posting Date

2005-08-22

Trade Name

Architect System Software V2.10 & 2.11

Recall Start Date

2005-06-23

Recall Number

28679

Hazard Classification

Type III

Model or Catalog #

1G06-01, 7-99077-01, 99077-103

Lot or Serial #

All serial numbers.

Reason for Recall

The software calculation utilizes 17ul rather than 12 ul for the alkaline washing solution dispensed, the displayed value for volume remaining will be less than the actual amount in the bottle.

Manufacturer

Abbott Laboratories Diagnostic Division

Recall Posting Date

2005-08-08

Trade Name

A) AXSYM Total B-HCG Reagent

B) IMX Total B-HCG Reagent

Recall Start Date

2005-04-05

Recall Number

28629

Hazard Classification

Type III

Model or Catalog #

A) 1A06-22
B) 7A59-22

Lot or Serial #

A) 26148Q100, 26278Q100, 16381Q100
B) 25459Q100

Reason for Recall

Tests have shown that protein aggregates are present in the specimen diluent and causes calibration errors and a shift in control values and no valid patient results could be generated.

Manufacturer

Abbott Laboratories Diagnostic Division

Recall Posting Date

2005-08-08

Trade Name

Axym Anti-TPO Reagent

Recall Start Date

2005-06-28

Recall Number

28675

Hazard Classification

Type III

Model or Catalog #

5F57-20

Lot or Serial #

22827HN00

Reason for Recall

Manufacturer has identified a manufacturing error at a contract facility in which a different reagent was mistakenly packed in its place for a subset of this reagent lot.

Manufacturer

Abbott Laboratories Diagnostic Division

Recall Posting Date

2005-08-08

Trade Name

Cell DYN 1800 System

Recall Start Date

2005-05-18

Recall Number

28635

Hazard Classification

Type III

Model or Catalog #

07H77-01

Lot or Serial #

19017AY

Reason for Recall

The HP6122 printer will print one page correctly but may have problems printing more than one page from the data log or the Qc log when "print data log" and "print Qc log" commands are given.

Manufacturer

Abbott Laboratories Diagnostic Division

Recall Posting Date

2005-08-08

Trade Name

TDX

Recall Start Date

2005-04-05

Recall Number

28653

Hazard Classification

Type III

Model or Catalog #

9797-02, 9797-12

Lot or Serial #

18229Q100, 18230Q100

Reason for Recall

Manufacturer has discovered a change in performance in which patient results are depressed 5-8%, elevated values when running a calibration curve.

Manufacturer

Abbott Laboratories Diagnostic Division

Recall Posting Date

2005-09-05

Trade Name

Abbott Corzyme

Recall Start Date

2005-04-01

Recall Number

28747

Hazard Classification

Type II

Model or Catalog #

9977-24

Lot or Serial #

18488M100, 15893M100, 16792M200, 10527M200, 23326M100, 19804M100

Reason for Recall

A study to compare the panels with a reference serum showed a difference in pei units

Manufacturer

Abbott Laboratories Diagnostic Division

Recall Posting Date

2005-09-05

Trade Name

Cell-DYN 4000 System

Recall Start Date

2005-03-17

Recall Number

28750

Hazard Classification

Type II

Model or Catalog #

01H01-01, 01H01-03, 01H02-01, 01H02-03, 01H03-01

Lot or Serial #

30268AA, 30271AA, 30455AA, 17500AA96, 30272AA, 30670AA, 287AA, 30266AA, 30403AA, 30653AA, 30654AA, 30697AA, 30416AA, 30488AA, 30665AA, 30672AA, 30615AA, 30709AA , 30712AA, 30686AA, 30683AA, 30723AA.

Reason for Recall

The optical platelet algorithm does not correctly gate the plto for the calibrator and the plus control and causes calibration problems and control plto results to fall outside the lower limit of assay range.

Manufacturer

Abbott Laboratories Diagnostic Division

Recall Posting Date

2005-09-05

Trade Name

Testpack Plus HCG Combo with OBC

Recall Start Date

2005-03-22

Recall Number

28752

Hazard Classification

Type II

Model or Catalog #

7B34-16

Lot or Serial #

16006M200, 19199M300

Reason for Recall

Manufacturer has received user complaints reporting occurrences of false positive results or weak positive colour on the patient bar for specimens where the results disagree with other methods.

Manufacturer

ACMI Corporation

Recall Posting Date

2005-08-22

Trade Name

ACMI Snap & Peel Introducer Sheaths

Recall Start Date

2005-06-30

Recall Number

28738

Hazard Classification

Type III

Model or Catalog #

60810BX, 61012BX

Lot or Serial #

1297324D, 1312704E, 1321584E, 1325384E, 1339994F, 1344104G, 1389384K, 1394004L, 1400154M, 1419225A, 1297374D, 1312724E, 1316954E, 1321644E, 1325394E, 1336944F, 1339964F, 1344094G, 1355274H, 1350354H, 1359054H, 1364234J, 1367404J, 1372814J, 1383294K, 1412604M, 1419235A, 1427565A, 1430855B, 1441195B

Reason for Recall

ACMI received a report from B. Braun, manufacturer of device, that there were cracks in the hub

Manufacturer

ADAC Laboratories, Inc.

Recall Posting Date

2005-08-22

Trade Name

Argus Epic Camera

Recall Start Date

2005-07-13

Recall Number

28730

Hazard Classification

Type II

Model or Catalog #

2145-3007A

Lot or Serial #

A0105217, 01548B, 03338B, 00000000009701075, 00964B, 00227BC, 01922B, 01920B, 01921B, 00000000009901158, 00000000009901157, 00709B, 00000000009908167, 00000000009801107, 01525B, A03030282, 01332B, 03041B, 01333B, 03094B, 01310B, 03368B

Reason for Recall

Fracture was discovered on an argus fork which holds the detector.

Manufacturer

Alsius Corporation

Recall Posting Date

2005-09-19

Trade Name

CoolGard 3000

Recall Start Date

2005-08-02

Recall Number

28831

Hazard Classification

Type I

Model or Catalog #

N

Lot or Serial #

465131

Reason for Recall

Coolgard 3000 units manufactured before April 12th, 2005, may overheat their coolant if left in a warm room, for prolonged periods in standby mode. At 44 c. Alarm will trigger and system latches.

Manufacturer

Anika Therapeutics Inc.

Recall Posting Date

2005-08-22

Trade Name

AMVISC

Recall Start Date

2005-07-25

Recall Number

28723

Hazard Classification

Type II

Model or Catalog #

59051, 59081

Lot or Serial #

B050120B, B050510B

Reason for Recall

Some cannulae packaged with AMVISC and AMVISC Plus Visoelastic may have an incomplete pouch seal.

Manufacturer

Bausch & Lomb Inc.

Recall Posting Date

2005-07-11

Trade Name

Purevision Toric Tinted Contact Lenses

Recall Start Date

2005-06-13

Recall Number

28497

Hazard Classification

Type II

Model or Catalog #

738

Lot or Serial #

W58405708, W58405713

Reason for Recall

Portion of two Purevision Toric product lots did not complete the required cycle time in the extraction and hydration process. As a result, residual extractable in the lenses exceeded specification.

Manufacturer

Baxter Healthcare Corporation

Recall Posting Date

2005-08-22

Trade Name

A) Homechoice Automated PD System

B) Homechoice Pro Automated PD System

Recall Start Date

2005-07-05

Recall Number

28726

Hazard Classification

Type II

Model or Catalog #

A) 5C4471

B) 5C8310, 5C8310P, 5C8310PE

Lot or Serial #

A) All serial numbers.
B) All serial numbers.

Reason for Recall

Remote risk of electrical shock from screws used to secure the power entry module to the back of the panel, this module is the electrical connector where the power cord plugs into the unit.

Manufacturer

Baxter Healthcare Corporation

Recall Posting Date

2005-08-08

Trade Name

A) Colleague 3 Volumetric Infusion Pump

B) Colleague Volumetric Infusion Pump

Recall Start Date

2005-07-21

Recall Number

28660

Hazard Classification

Type I

Model or Catalog #

A) 2M8153, 2M8163, DNM8153

B) 2M8151, 2M8161, DNM8151

Lot or Serial #

A) All Serial Numbers
B) All Serial Numbers

Reason for Recall

Design problem with the clocking circuit that can disrupt internal communications causing the pumps to shut down with certain error codes and disrupt critical medication infusions. Death has been involved.

Manufacturer

Baxter Healthcare Corporation

Recall Posting Date

2005-07-11

Trade Name

A) Homechoice Pro PD Aut. System-Software

B) PBO Enal Link

Recall Start Date

2005-06-23

Recall Number

28534

Hazard Classification

Type II

Model or Catalog #

A) R5C4532, R5C4534
B) 5M5590

Lot or Serial #

A) Renal Software Suite
B) Renal Software Suite

Reason for Recall

This is a followup to the recall of April 2004 regarding an anomaly that may occur when changing the name of a medication, Baxter is now providing a cd with a software upgrade.

Manufacturer

Baxter Healthcare Corporation

Recall Posting Date

2005-07-11

Trade Name

A) Model 6060 Homerun Vol. Infusion Pump

B) Model 6060 Homerun Vol. Infusion Pump

Recall Start Date

2005-06-22

Recall Number

28512

Hazard Classification

Type II

Model or Catalog #

A) 2M9832, 2M9832R, 60600040IR
B) 60600043, D2M9832

Lot or Serial #

A) All Serial Numbers
B) All Serial Numbers

Reason for Recall

Manufacturer is issuing a notice to all users on two issues 1)specific keystrokes sequence can result in over-infusion, 2)to safeguard the security codes that allow programming pump parameters.

Manufacturer

Baxter Healthcare Corporation

Recall Posting Date

2005-07-11

Trade Name

Configuration Transfer Cable

Recall Start Date

2005-03-14

Recall Number

28488

Hazard Classification

Type III

Model or Catalog #

2M8155

Lot or Serial #

50604

Reason for Recall

Baxter has been provided and distributed cables with incorrect dimensions on the thumbscrews that attach to the colleague pump, the thumbscrews were not manufactured to baxter specifications.

Manufacturer

Beckman Coulter Inc.

Recall Posting Date

2005-09-05

Trade Name

StemCXP Software Version 1.0

Recall Start Date

2005-06-09

Recall Number

28471

Hazard Classification

Type III

Model or Catalog #

628843

Lot or Serial #

N

Reason for Recall

7HPCSA and 7HPCSA control protocols may not invoke the algorithm under certain conditions.

Manufacturer

Beckman Coulter Inc.

Recall Posting Date

2005-09-05

Trade Name

LH 1500 Series Lab Automation System

Recall Start Date

2005-06-23

Recall Number

28510

Hazard Classification

Type III

Model or Catalog #

6605528

Lot or Serial #

N

Reason for Recall

Warnings in manual conflict with sections in the manual. Potential for mechanical and voltage hazards during maintenance.

Manufacturer

Beckman Coulter Inc.

Recall Posting Date

2005-09-05

Trade Name

Synchron Systems Amphetamine Reagent

Recall Start Date

2005-07-07

Recall Number

28607

Hazard Classification

Type III

Model or Catalog #

475000

Lot or Serial #

M501225, M503380

Reason for Recall

These lots have different than expected cross reactivities. May cause false positive amphetamine results in patients taking medications containing ephedrine.

Manufacturer

Beckman Coulter Inc.

Recall Posting Date

2005-09-05

Trade Name

A) Immage Low Conc. IgA (IGALC) Reagent

B) Immage Low Conc. IgM (IGALC) Reagent

Recall Start Date

2005-04-17

Recall Number

28610

Hazard Classification

Type III

Model or Catalog #

A) 447460
B) 447470

Lot or Serial #

A) All lots
B) All Lots

Reason for Recall

Reagents do not meet performance claim.

Manufacturer

Beckman Coulter Inc.

Recall Posting Date

2005-09-05

Trade Name

Access Immunoassay Unconj Estriol Calib

Recall Start Date

2005-07-14

Recall Number

28643

Hazard Classification

Type III

Model or Catalog #

33575

Lot or Serial #

416534

Reason for Recall

Does not meet expiration claim of 12 months.

Manufacturer

Beckman Coulter Inc.

Recall Posting Date

2005-09-05

Trade Name

Paragon CZE 2000 Software Version 2.0

Recall Start Date

2005-07-27

Recall Number

28734

Hazard Classification

Type III

Model or Catalog #

A09744

Lot or Serial #

N

Reason for Recall

Potential for incorrect results to be displayed and printed out.

Manufacturer

Beckman Coulter Inc.

Recall Posting Date

2005-09-05

Trade Name

Remisol 2000 Data Manager System

Recall Start Date

2005-06-27

Recall Number

28505

Hazard Classification

Type III

Model or Catalog #

A27343

Lot or Serial #

N

Reason for Recall

Results may upload with an incorrect or blank sample ID.

Manufacturer

Beckman Coulter Inc.

Recall Posting Date

2005-09-05

Trade Name

A) Access Immunoassay Sys: Dil-AFP

B) Access Immunoassay Sys: Dil-AFP

Recall Start Date

2005-07-21

Recall Number

28789

Hazard Classification

Type III

Model or Catalog #

A) 33211
B) 33210

Lot or Serial #

A) All lots.

B) All lots

Reason for Recall

Potential splashing may cause erroneous results.

Manufacturer

Beckman Coulter Inc.

Recall Posting Date

2005-09-19

Trade Name

Synchron CRP

Recall Start Date

2005-07-18

Recall Number

28832

Hazard Classification

Type II

Model or Catalog #

N

Lot or Serial #

N

Reason for Recall

Synchron CRP turbidimetric assay may not be sensitive or specific enough as a sole diagnostic marker of infection in neonates.

Manufacturer

Beckman Coulter, Inc.

Recall Posting Date

2005-08-08

Trade Name

Access Immuno Sys Unconj Estriol Calib

Recall Start Date

2005-07-14

Recall Number

28643

Hazard Classification

Type III

Model or Catalog #

33575

Lot or Serial #

416534

Reason for Recall

Device does not meet expiration claim of 12 months.

Manufacturer

Beckman Coulter, Inc.

Recall Posting Date

2005-08-08

Trade Name

Synchron Clinical Sys. Alcohol Reagent

Recall Start Date

2005-05-17

Recall Number

28371

Hazard Classification

Type III

Model or Catalog #

91DIC

Lot or Serial #

UPDATED RECALL # 28371 PREVIOUSLY POSTED ON 2005-06-27.
M405028, M409024, M407255, M412090, M503108

Reason for Recall

Reagent is past expiry date thus will not produce results since it cannot calibrate successfully.

Manufacturer

Beckman Coulter, Inc.

Recall Posting Date

2005-07-11

Trade Name

Access Immunoassay Prolactin Calibrator

Recall Start Date

2005-03-24

Recall Number

27979

Hazard Classification

Type III

Model or Catalog #

N

Lot or Serial #

419474

Reason for Recall

This calibrator lot will not support the open vial storage recommendations of the 2 months at 2 to 10 degrees c. This issue could effect patient results.

Manufacturer

Beckman Coulter, Inc.

Recall Posting Date

2005-07-11

Trade Name

Coulter 5C Cell Control

Recall Start Date

2005-03-09

Recall Number

27862

Hazard Classification

Type III

Model or Catalog #

N

Lot or Serial #

111220K-111224K for PN 624506, 102866K-102880K for PN 7547001, 102785K-102794K for PN 7547002, 869400F-869900F for PN 7547011, 100128K-100152K for PN 7547116, 112198K-112101K for PN 7547124, 100348K-100351K for PN 7547199

Reason for Recall

The recovery of the MCV parameter for the abnormal II level of coulter 5c cell control may recover values above the upper expected range limit.

Manufacturer

Becton Dickinson

Recall Posting Date

2005-08-08

Trade Name

BD DTXPlus Disposable Transducer Kit

Recall Start Date

2005-06-29

Recall Number

28624

Hazard Classification

Type II

Model or Catalog #

682000, 682034

Lot or Serial #

407032, 407104

Reason for Recall

Device (stopcock tap) may easily detach from the stopcock and cause leakage of the iv fluids and

Manufacturer

Becton Dickinson

Recall Posting Date

2005-07-25

Trade Name

Bd Unopette - RBC Osmotic Fragility Determination for Manual Methods

Recall Start Date

2005-06-27

Recall Number

28536

Hazard Classification

Type II

Model or Catalog #

365830

Lot or Serial #

5014328

Reason for Recall

Lot may have a problem that could cause an increased susceptibility for lysis of red cells from normal subjects. Yields uninterpretable results and causing the test results to not be generated.

Manufacturer

Biomerieux, Inc.

Recall Posting Date

2005-09-05

Trade Name

A) Simplastin Excel

B) Simplastin L

C) Simplastin - Excel S

Recall Start Date

2005-08-08

Recall Number

28780

Hazard Classification

Type I

Model or Catalog #

A) N/A
B) N/A
C) N/A

Lot or Serial #

A) 161711, 161929, 161897
B) 161750
C) 161720, 161760, 161761, 161783, 161811

Reason for Recall

The ISI values published in the package insert of Simplastin Excel products are incorrect for the devices: fibrometer (mechanical), option, XM and MTX (photo optic).

Manufacturer

Cardiac Pacemakers Inc. A Wholly Owned Subsidiary of Guidant

Recall Posting Date

2005-08-08

Trade Name

A) Contak Renewal 4 AVT

B) Contak Renewal 4 AVT HE

C) Ventak Prizm AVT

D) Vitality AVT AICD

Recall Start Date

2005-07-22

Recall Number

28665

Hazard Classification

Type II

Model or Catalog #

A) M170, M175

B) M177

C) 1900

D) A155

Lot or Serial #

A) N/A

B) N/A

C) N/A

D) N/A

Reason for Recall

One of the original recommendations to recall #28528 - programming atrial tachy episode data storage to 0% - can cause latching in a subset of AVT devices that have previously stored atrial episode data.

Manufacturer

Cardiac Pacemakers Inc. A Wholly Owned Subsidiary of Guidant

Recall Posting Date

2005-08-08

Trade Name

A) Contak TR CHFD

B) CPI Discovery DR Pacemaker

C) CPI Discovery SR Pacemaker

D) CPI Meridian DDD Pacemaker

E) CPI Meridian DR Pacemaker

F) CPI Meridian SR Pacemaker

G) CPI Meridian SSI Pacemaker

H) CPI Pulsar DDD, Model 970 Pacemaker

I) CPI Pulsar DDD, Model 972 Pacemaker

J) CPI Pulsar DR Pacemaker

K) CPI Pulsar Max DR Pacemaker

L) CPI Pulsar Max SR, Model 1170 Pacemaker

M) CPI Pulsar Max SR, Model 1171 Pacemaker

N) CPI Pulsar SSI Pacemaker

O) CPI Pulsar VDD Pacemaker

P) Discovery II DDD

Q) Discovery II DR

R) Discovery II SR

S) Discovery II SSI

T) Pulsar Max II Pacemaker DDDR

U) Pulsar Max II Pacemaker SSIR

W) CPI Pulsar SR Pacemaker

Recall Start Date

2005-07-19

Recall Number

28650

Hazard Classification

Type I

Model or Catalog #

A) 1241

B) 1273, 1274, 1275

C) 1174, 1175

D) 976

E) 1276

F) 1176

G) 476

H) 970

I) 972

J) 1272

K) 1270

L) 1170

M) 1171

N) 470

O) 870

P) 981

Q) 1283, 1284, 1285, 1286

R) 1184, 1186, 1187

S) 481

T) 1280

U) 1180, 1181

W) 1172

Lot or Serial #

A) N/A

B) N/A

C) N/A

D) N/A

E) N/A

F) N/A

G) N/A

H) N/A

I) N/A

J) N/A

K) N/A

L) N/A

M) N/A

N) N/A

O) N/A

P) N/A

Q) N/A

R) N/A

S) N/A

T) N/A

U) N/A

W) N/A

Reason for Recall

Hermetic sealing component may experience a gradual degradation, resulting in a higher than normal moisture content within the pacemaker Case late in the device's service life.

Manufacturer

Cardiac Pacemakers Inc. A Wholly Owned Subsidiary of Guidant

Recall Posting Date

2005-07-25

Trade Name

A) Contak Renewal 2

B)Contak Renewal

Recall Start Date

2005-06-21

Recall Number

28519

Hazard Classification

Type II

Model or Catalog #

A) H135

B) H155

Lot or Serial #

A) N/A

B) N/A

Reason for Recall

Deterioration in a wire insulator within the lead connector block, could cause a short circuit and loss of device function due to diversion of therapy energy away from the heart and into device circuitry.

Manufacturer

Cardiac Pacemakers Inc. A Wholly Owned Subsidiary of Guidant

Recall Posting Date

2005-07-25

Trade Name

A) Contak Renewal 4 AVT

B) Contak Renewal 4 AVT HE

C) Contak Renewal 4

D) Contak Renewal 4 HE

Recall Start Date

2005-06-24

Recall Number

28531

Hazard Classification

Type II

Model or Catalog #

A) M170, M175

B) M177, M179

C) H190, H195

D) H197, H199

Lot or Serial #

A) N/A

B) N/A

C) N/A

D) N/A

Reason for Recall

Component failure may limit available tachyarrhythmia therapy. The magnetic switch might stick in the closed position.

Manufacturer

Cardiac Pacemakers Inc. A Wholly Owned Subsidiary of Guidant

Recall Posting Date

2005-07-25

Trade Name

A) Contak Renewal 4 AVT

B) Contak Renewal 4 AVT HE

C) Ventak Prizm AVT

D) Vitality AVT

Recall Start Date

2005-06-21

Recall Number

28528

Hazard Classification

Type II

Model or Catalog #

A) M170, M175

B) M177, M179

C) 1900

D) A135, A155

Lot or Serial #

A) N/A

B) N/A

C) N/A

D) N/A

Reason for Recall

Random memory error causes functional "latching" that limits available therapy. Latching can only occur when storing tachy detection

Manufacturer

CTI Pet Systems Inc.

Recall Posting Date

2005-08-08

Trade Name

Biograph Duo LSO

Recall Start Date

2005-07-12

Recall Number

28625

Hazard Classification

Type III

Model or Catalog #

8415957

Lot or Serial #

5408-0301009

Reason for Recall

Under certain circumstances the system will continue to scan after an IRS function failure occurs. The system will scan only until the end of the planned sequence and then will shut off.

Manufacturer

Dade Behring Marburg GMBH

Recall Posting Date

2005-08-08

Trade Name

Clotting Factor 8 Deficient Plasma

Recall Start Date

2005-07-01

Recall Number

28642

Hazard Classification

Type II

Model or Catalog #

OTXW17

Lot or Serial #

503848A, 503849E, 503850C, 503856B, 503858A, 503860D,

Reason for Recall

Manufacturer has determined that these lots do not demonstrate acceptable performance and patient samples may exhibit falsely high factor viii results, could lead to misdiagnosis.

Manufacturer

Dade Behring Marburg GMBH

Recall Posting Date

2005-07-25

Trade Name

Behring Nephelometer Pro Spec Analyzer

Recall Start Date

2005-06-24

Recall Number

28589

Hazard Classification

Type III

Model or Catalog #

400252.1003

Lot or Serial #

420926, 341237, 241226, 141169, 331087, 490129, 100215, 410745, 410737, 120753, 310622, 410720, 300392, 310624, 310667, 210615, 210582, 210579, 210613A, 110540, 210577, 210545, 110539, 400476,

Reason for Recall

Manufacturer has received reports that flags "l" and "h" indicating results below and above the reference range may not be correct for formula assays.

Manufacturer

Dade Behring, Inc.

Recall Posting Date

2005-07-25

Trade Name

Microstrep Plus 1

Recall Start Date

2005-06-23

Recall Number

28563

Hazard Classification

Type III

Model or Catalog #

B1027-201

Lot or Serial #

2005-08-06, 2006-01-14, 2006-01-25, 2006-02-24

Reason for Recall

There is a potential for out of range (high) quality control Clindamycin results for ATC'S. pneumoniae 49619 and

Manufacturer

Dade Behring, Inc.

Recall Posting Date

2005-07-25

Trade Name

Quicklyte Sensor Cartridge

Recall Start Date

2005-06-17

Recall Number

28555

Hazard Classification

Type III

Model or Catalog #

S600

Lot or Serial #

5CD813, 5CD816, 5DD817, 5DD8120

Reason for Recall

Manufacturer has confirmed that urine chloride test results in patients, qc and proficiency survey samples may be elevated by 10-15%.

Manufacturer

Dade Behring, Inc.

Recall Posting Date

2005-07-11

Trade Name

DIM RCRP Rev C-Reactive PRTN Flex 120TS

Recall Start Date

2005-05-25

Recall Number

28487

Hazard Classification

Type III

Model or Catalog #

DF34

Lot or Serial #

DH5341, EG5300

Reason for Recall

Manufacturer has determined a stability issue with the particle reagent and may result in inability to calibrate, flagged results, imprecision of inaccuracy, QC results shift high or low, error message.

Manufacturer

Diagnostica Stago

Recall Posting Date

2005-08-22

Trade Name

STAGO ATA R System

Recall Start Date

2005-06-08

Recall Number

28662

Hazard Classification

Type III

Model or Catalog #

57160

Lot or Serial #

All serial numbers.

Reason for Recall

Manufacturer determined there is potential defect relating to change of disposable cuvette roll change, filled cuvettes may wait on the conveyer belt prolonging contact time with plasma & intermediate regent.

Manufacturer

Disetronic Medical Systems AG

Recall Posting Date

2005-08-22

Trade Name

D-TRON Plus Adapter

Recall Start Date

2005-07-16

Recall Number

28683

Hazard Classification

Type I

Model or Catalog #

3000803

Lot or Serial #

N/A

Reason for Recall

Incorrect function may occur within 15 min of replacing the adapter and priming the set. The drop in pressure may result in the delivery of up to 1.8 units of insulin which affects users 13 years and under.

Manufacturer

Disetronic Medical Systems AG

Recall Posting Date

2005-08-08

Trade Name

D-TRON Plus Adapter

Recall Start Date

2005-07-06

Recall Number

28686

Hazard Classification

Type II

Model or Catalog #

3000803

Lot or Serial #

part # 3000803

Reason for Recall

Small percentage of adapters may drop in pressure which may result in the delivery of up to 1.8 units of insulin. This may occur within 15 minutes of replacing the adapter and priming the set.

Manufacturer

ELA Medical, S.A.

Recall Posting Date

2005-09-05

Trade Name

A) Alto VR625 Cardioverter Defibrillator

B) Alto DR614 Cardioverter Defibrillator

C) Alto 2 DR624 Cardioverter Defibrillator

Recall Start Date

2005-07-20

Recall Number

28746

Hazard Classification

Type I

Model or Catalog #

A) N/A

B) 614

C) N/A

Lot or Serial #

A) 304XI002, 304XI108, 402XI001, 404XI049, 413XI027, 413XI035

B) 222XF028, 222XF035, 222XF085, 222XF079, 222XF033

C) 314XJ284, 238XJ029, 403XJ002, 403XJ092, 409XJ014, 409XJ036, 410XJ019, 410XJ024, 410XJ025, 410XJ031, 410XJ042

Reason for Recall

Premature battery depletion and

Manufacturer

Electro Medical Systems (EMS) SA

Recall Posting Date

2005-07-25

Trade Name

Swiss Lithoclast Ultrasound Handpiece

Recall Start Date

2005-06-17

Recall Number

28544

Hazard Classification

Type II

Model or Catalog #

FR-093

Lot or Serial #

20124, 20172, 20268, 29342, 20372, 20403, 20406

Reason for Recall

Manufacturer has become aware that handpieces have twisted cables and there is a small possibility that they may not function properly or the function may diminish over time.

Manufacturer

Euro

Recall Posting Date

2005-07-11

Trade Name

Immulite CEA

Recall Start Date

2005-05-25

Recall Number

28484

Hazard Classification

Type II

Model or Catalog #

LKCE1

Lot or Serial #

302, 303

Reason for Recall

Manufacturer has determined an adverse trend in stability which may result in significant decrease in adjustment slopes and a positive shift of 20-30% at low conc., 20% at higher conc. of patient results.

Manufacturer

Gambro Dasco S.P.A.

Recall Posting Date

2005-08-08

Trade Name

Prismaflex Software 1.07.3 KJ

Recall Start Date

2005-05-27

Recall Number

28506

Hazard Classification

Type II

Model or Catalog #

6023014700

Lot or Serial #

All serial numbers

Reason for Recall

Pumps may stop while green light is on with no audible alarm. No hemodynamic problems but access eventually clot as well as lost blood in set.

Manufacturer

Gambro Dasco S.P.A.

Recall Posting Date

2005-09-05

Trade Name

Prisma Continuous Replacement System

Recall Start Date

2005-08-16

Recall Number

28774

Hazard Classification

Type I

Model or Catalog #

N

Lot or Serial #

N

Reason for Recall

Serious injuries or deaths have resulted because of excessive ultrafiltration. This can occur when the cause of the "incorrect weight change detected" alarm is not identified and removed by the user.

Manufacturer

Guidant Corporation Cardiac Surgery

Recall Posting Date

2005-08-08

Trade Name

Heartstring II Proximal Seal System

Recall Start Date

2005-07-07

Recall Number

28623

Hazard Classification

Type II

Model or Catalog #

N

Lot or Serial #

N

Reason for Recall

Failure modes include incomplete or no Aortotomy with use of device on unaltered tissue, or incomplete Aortotomy when device is used on altered tissue (e.g. Cardioplegia hole or Aortotomy incision).

Manufacturer

Immucor Inc.

Recall Posting Date

2005-09-19

Trade Name

Galileo Immuno Haematology System

Recall Start Date

2005-06-30

Recall Number

28664

Hazard Classification

Type II

Model or Catalog #

64999

Lot or Serial #

N

Reason for Recall

The immediate spin crossmatch (IS_XM) assay performed on the Galileo may not give the expected incompatible result.

Manufacturer

Implant Innovations, Inc.

Recall Posting Date

2005-07-11

Trade Name

ITHA52 Healing Abutments

Recall Start Date

2005-05-18

Recall Number

28369

Hazard Classification

Type III

Model or Catalog #

ITHA52

Lot or Serial #

330918

Reason for Recall

The colour code on the label to identify the implant platform diameter was incorrect. The label has a yellow stripe instead of a blue stripe.

Manufacturer

Instrumentation Laboratory Co.

Recall Posting Date

2005-09-19

Trade Name

A) ACL Futur A/ACLl Advance

B) ACL Top

Recall Start Date

2005-05-19

Recall Number

28468

Hazard Classification

Type II

Model or Catalog #

A) 280000, 999001

B) N/A

Lot or Serial #

A)Serial number starting with 05041164, Serial number with 0505354.

B) N/A

Reason for Recall

Patient prothrombin time (PT) may report low for individuals on anticoagulent therapy.

Manufacturer

I-Stat Corporation

Recall Posting Date

2005-09-05

Trade Name

I-Stat G3+ Cartridges

Recall Start Date

2005-08-05

Recall Number

28778

Hazard Classification

Type III

Model or Catalog #

N

Lot or Serial #

L05048, L05088

Reason for Recall

Certain lots of I-stat G3+ cartridges may exhibit higher than expected rates of star-outs (***) in place of oxygen results.

Manufacturer

Keir Surgical Ltd.

Recall Posting Date

2005-09-19

Trade Name

Pyramidal Tip Obturator

Recall Start Date

2005-08-09

Recall Number

28751

Hazard Classification

Type I

Model or Catalog #

KS81-1055

Lot or Serial #

KS81-1055

Reason for Recall

Distal tip of obturator, lot# 10123, separated from the proximal shaft. A recent affected device was found after initial company recall done on April 2002.

Manufacturer

Kyphon Inc.

Recall Posting Date

2005-07-11

Trade Name

KyphX HV-R Bone Cement

Recall Start Date

2005-03-14

Recall Number

27927

Hazard Classification

Type III

Model or Catalog #

N

Lot or Serial #

EL08304

Reason for Recall

US version of the instructions for use accompanied product sent to Canada.

Manufacturer

Lifescan Inc.

Recall Posting Date

2005-08-22

Trade Name

One Touch UltraSmart Meter

Recall Start Date

2005-06-15

Recall Number

28489

Hazard Classification

Type III

Model or Catalog #

011-555, 020-720

Lot or Serial #

All lots.

Reason for Recall

Glucose meter does not prompt user to take a snack at glucose levels over the entire range of 1.1MMOL

Manufacturer

Lifescan Inc.

Recall Posting Date

2005-09-05

Trade Name

One Touch UltraSmart Meter

Recall Start Date

2005-06-15

Recall Number

28489

Hazard Classification

Type III

Model or Catalog #

011-555, 020-720

Lot or Serial #

All lots.

Reason for Recall

CORRECTION TO RECALL # 28489 PREVIOUSLY POSTED ON 2005-08-22.

Labelling incorrectly states that the 'snack' message will appear on .Meter between 1.1mmol/l to 3.9 mmol/l, labelling should state between 1mmol/l to 3.3 mmol/l.

Manufacturer

Masimo Corporation

Recall Posting Date

2005-07-25

Trade Name

Set Radical Handheld Pulse Oximeter

Recall Start Date

2005-06-13

Recall Number

28558

Hazard Classification

Type II

Model or Catalog #

N

Lot or Serial #

Less than or equal to 102999 - P3027 through P3148

Reason for Recall

The internal speaker could fail to produce an audio alarm during an alarm condition. The affected units were manufactured prior to December 11, 2001.

Manufacturer

MISYS Healthcare Systems Inc.

Recall Posting Date

2005-08-08

Trade Name

MISYS Laboratory System Blood Bank

Recall Start Date

2005-05-10

Recall Number

28492

Hazard Classification

Type III

Model or Catalog #

N

Lot or Serial #

Sites using software ver. 6.1

Reason for Recall

CORRECTION TO RECALL # 28492 PREVIOUSLY POSTED ON 2005-07-11.

Information entered into the comment field may be lost when resulting the blood type for the first time via a blood bank instrument interface. The software problem will be corrected with the installation of a software patch.

Manufacturer

MISYS Healthcare Systems Inc.

Recall Posting Date

2005-07-11

Trade Name

MISYS Laboratory System

Recall Start Date

2005-05-13

Recall Number

28491

Hazard Classification

Type I

Model or Catalog #

SQI-MIC-SY

Lot or Serial #

LARS versions 5.3 or later

Reason for Recall

In rare situations, modification of previously reported specimen results using the lars application, may modify other previously filed results on the same specimen.

Manufacturer

MISYS Healthcare Systems Inc.

Recall Posting Date

2005-07-11

Trade Name

MISYS Laboratory System Blood Bank

Recall Start Date

2005-05-10

Recall Number

28492

Hazard Classification

Type III

Model or Catalog #

N

Lot or Serial #

Sites using software ver. 6.1

Reason for Recall

When a previously reported microbiology organism result is deleted on a selected patient, reported susceptibilities will not stay with associated organisms and one or more susceptibilities may be deleted.

Manufacturer

Nichols Institute Diagnostics

Recall Posting Date

2005-07-25

Trade Name

Bio-intact PTH (I-84) Assay

Recall Start Date

2005-03-25

Recall Number

28457

Hazard Classification

Type II

Model or Catalog #

62-7040

Lot or Serial #

62-402622

Reason for Recall

Internal testing indicates that the assay does not meet the following performance specifications stated in the directional insert functional sensitivity, reproducibility, parallelism, recover and interfaces.

Manufacturer

Philips Medical Systems (Cleveland), Inc.

Recall Posting Date

2005-08-08

Trade Name

A) Brilliance CT 16 Slice

B) Brilliance CT 16 Power

C) Brilliance CT 40 Channel

Recall Start Date

2005-07-18

Recall Number

28640

Hazard Classification

Type II

Model or Catalog #

A) 453567078851

B) 453567005721

C) 455011004011

Lot or Serial #

A) 5074

B) 6110

C) 9081, 6072

Reason for Recall

Couch positions that are reported on the gantry control panel are correct during a CCT procedure, but the couch positions that are displayed on the monitor may be incorrect.

Manufacturer

Philips Medical Systems (Cleveland), Inc.

Recall Posting Date

2005-09-19

Trade Name

Gemini GXL 6

Recall Start Date

2005-08-25

Recall Number

28819

Hazard Classification

Type II

Model or Catalog #

4535 679 72021

Lot or Serial #

4004

Reason for Recall

An anomaly was identified in the gemini ct image reconstruction subsystem of the Gemini GXL Pet

Manufacturer

Philips Medical Systems Nederland B.V.

Recall Posting Date

2005-07-11

Trade Name

Viewforum Software

Recall Start Date

2005-05-27

Recall Number

28501

Hazard Classification

Type II

Model or Catalog #

M1M1171

Lot or Serial #

5V9371J, 00F1F8B16DA, 00F1F9385CE

Reason for Recall

The "automated analysis of vascular obstruction" tool in the Viewforum 2003 software gives unreliable calibration and analysis results when using unprocessed images acquired on the Philips Allura FD10.

Manufacturer

Radiotherapeutics Corporation

Recall Posting Date

2005-08-22

Trade Name

Leveen Coaccess Electrode

Recall Start Date

2005-08-02

Recall Number

28745

Hazard Classification

Type II

Model or Catalog #

26-216, 26-217

Lot or Serial #

7108067, 6556464, 6826039, 6666258, 6556462, 7356251, 31804, 7021736, 7091462, 21403R, 6558336, 6538341, 6556258, 6538336, 7257089, 7481332

Reason for Recall

Manufacturer has received reports of extended ablation times, lack of roll-off, and

Manufacturer

Richard Wolf GMBH

Recall Posting Date

2005-09-05

Trade Name

Scissors Insert for Single Use

Recall Start Date

2005-04-29

Recall Number

28206

Hazard Classification

Type II

Model or Catalog #

8392.0403, 8393.0403, 8394.0403

Lot or Serial #

953046, 9532217, 953486

Reason for Recall

Damage to the insulation part may arise by unintentional "jamming" of the scissor on the existing edges in the access instrument when being introduced or pulled out. Insulation material may come off and fall.

Manufacturer

Roche Molecular Systems, Inc.

Recall Posting Date

2005-07-11

Trade Name

Six-Part Bar Code Labels, Sarstedt Tubes

Recall Start Date

2005-05-17

Recall Number

28326

Hazard Classification

Type I

Model or Catalog #

N

Lot or Serial #

28868, 029213

Reason for Recall

Rolls of six-part bar code labels, roche M

Manufacturer

Sensormedics Corporation

Recall Posting Date

2005-08-08

Trade Name

Dell AC Adapter

Recall Start Date

2005-03-11

Recall Number

28669

Hazard Classification

Type III

Model or Catalog #

22536, 22538

Lot or Serial #

N

Reason for Recall

Dell recalled the adapter units due to a risk of overheating which could lead to fire and electrical shock. The adapters are used in conjunction with laptops-peripheral components of vmax and sleep systems.

Manufacturer

Siemens Aktiengesellschaft

Recall Posting Date

2005-08-22

Trade Name

A) Axiom Artis BA

B) Axiom Artis DFC

C) Axiom Artis FA ALPHA

D) Axiom Artis MP

E) Axiom Artis TA

Recall Start Date

2005-07-26

Recall Number

28718

Hazard Classification

Type III

Model or Catalog #

A) 5904656

B) 7412807, 7727717

C) 5904441

D) 5904466

E) 7007755

Lot or Serial #

A) N/A

B) 35195, 35261, 35219, 35298, 40033, 25006, 25076, 20070, 20215, 28064, 32070

C) N/A

D) N/A

E) N/A

Reason for Recall

The live display of the Axiom Artis in the examination room may sporadically stop working.

Manufacturer

Siemens Aktiengesellschaft

Recall Posting Date

2005-07-25

Trade Name

Axiom Multistar

Recall Start Date

2005-06-17

Recall Number

28539

Hazard Classification

Type III

Model or Catalog #

3772501, 3773004

Lot or Serial #

1027, 1094, 1142, 1163, 1229, 1290, 1795, 1818, 1102, 1112, 1113, 1129

Reason for Recall

A system error may occur which results in unintended movement during examination.

Manufacturer

Siemens Aktiengesellschaft

Recall Posting Date

2005-07-11

Trade Name

A) Axiom Aristos FX

B) Axiom Aristos MX

Recall Start Date

2005-06-14

Recall Number

28493

Hazard Classification

Type III

Model or Catalog #

A) 7414803

B) 5895003

Lot or Serial #

A) 1298, 1120, 1129, 1131, 1292, 1288, 1086, 1236, 1006, 1243, 1018, 1311, 1315, 1326, 1340, 1354, 1153, 1443, 1337, 1173, 1190, 1244, 1072,
1273, 1175, 1124, 1134, 1272, 1333, 1145, 1386,1065, 1328, 1162, 1128, 1119, 1176.

B) N/A

Reason for Recall

A system lock-up may occur when repeating patient registrations under a specific workflow.

Manufacturer

Siemens Aktiengesellschaft

Recall Posting Date

2005-07-11

Trade Name

Magnetom Avanto System

Recall Start Date

2005-06-21

Recall Number

28493

Hazard Classification

Type II

Model or Catalog #

7391167

Lot or Serial #

25285, 25340, 25043, 25039, 25234, 25173, 25089, 25110, 25066, 25137, 25049, 25097, 25311, 25168, 25333, 25224

Reason for Recall

For the safety of the service technicians, the acc power connection X102 need to be checked and labelled.

Manufacturer

Siemens Aktiengesellschaft

Recall Posting Date

2005-09-05

Trade Name

A) Arcadis Varic

B) Siremobil Compact

Recall Start Date

2005-08-08

Recall Number

28754

Hazard Classification

Type III

Model or Catalog #

A) 8080017

B) 3780629

Lot or Serial #

A) N/A

B) 10051, 10243, 10256, 1639

Reason for Recall

The screws fixing the laser diode out windows can become loosened.

Manufacturer

Siemens Aktiengesellschaft

Recall Posting Date

2005-09-05

Trade Name

A) Magnetom Avanto System

B) Manetom Espree

Recall Start Date

2005-08-18

Recall Number

28779

Hazard Classification

Type II

Model or Catalog #

A) 7391167

B) 7727121

Lot or Serial #

A) N/A


B) 25285, 25490, 25340, 25043, 30048, 25039, 25541, 25234, 25462, 25173, 25089, 25526, 25110, 25066, 25137, 25486, 25049, 25097, 25311, 25168, 25333, 25555, 25244

Reason for Recall

A misalignment of the patient table may occur between the patient table assembly and the opening to the magnet bore.

Manufacturer

Siemens Medical Solutions USA, Inc.

Recall Posting Date

2005-07-25

Trade Name

Sonoline Antares Diagnostic Ultrasound

Recall Start Date

2005-06-05

Recall Number

28540

Hazard Classification

Type II

Model or Catalog #

5936518

Lot or Serial #

112607, 112593, 112609, 112611, 112530, 112595, 112612, 112687, 112610, 10077, 10145, 10280, 111223, 111233, 111234, 112579, 10438, 111197, 112736, 10068, 111843, 111922, 111923, 111639, 111643, 111660, 111666, 10928, 11092, 11096, 112658, 112666, 10838, 10925, 112237, 10134, 112267, 112070, 112073, 10940, 111166

Reason for Recall

Error occurs after performing a labeled measurement on a frozen waveform utilizing a 2d image and an angle-corrected pulse wave doppler waveform.

Manufacturer

Smith & Nephew, Inc. Orthopaedic Division

Recall Posting Date

2005-07-11

Trade Name

Compression Hip Screw System-Lag Screw

Recall Start Date

2005-04-11

Recall Number

28190

Hazard Classification

Type III

Model or Catalog #

12-1108

Lot or Serial #

04LT84854

Reason for Recall

Chart stick label and inner tyvek pouch label state that the product is a hex screwdriver. The outside label correctly identifies the product.

Manufacturer

STAAR Surgical Company

Recall Posting Date

2005-08-22

Trade Name

STAAR Surgical STAARVISC II

Recall Start Date

2005-07-18

Recall Number

28728

Hazard Classification

Type II

Model or Catalog #

N

Lot or Serial #

B041118C

Reason for Recall

The cannula package has not been validated to a sterility assurance level (sal) of 0.000001 and therefore the sterility can not be assured.

Manufacturer

Sysmex Corporation

Recall Posting Date

2005-08-22

Trade Name

A) CA1500 Instrument

B) CA540 Instrument

C) CA560 Instrument

Recall Start Date

2005-07-21

Recall Number

28685

Hazard Classification

Type II

Model or Catalog #

A) CA-1500WBCR

B) B4260-540

C) B4260-560

Lot or Serial #

A) A2399, A2483, A2400, A3358, A2401, A2727, A1888, A3295, A3276, A3632, A2620, A2739, A1825, A2270, A2753, A2522, A1556, A3905, A2480, A4001, A2636, A3546, A2320, A1465, A1151, A2646, A4047, A4050, A3548, A2713, A2269, A2271, A3634, A1646, A2182, A2170, A3521, A4028, A2171, A3284, A1105, A1581, A2427, A2257, A2632, A2621, A1644, A2296.

B) A3616, A2858, A3359, A2530, A2578, A2353, A2536, A3250, A1307, A2384, A3637, A1449, A2993, A2954, A3729, A2352, A3406, A3249, A2005, A2996, A2246, A2854, A2308, A3273, A3274, A3687, A3360, A2841, A1452, A3482, A2859, A3407, A3403, A2474, A2351, A2953, A1309, A2027, A2248, A3636, A2997, A3602, A3477, A3600, A3599, A3345, A2861, A2309, A2995, A2532, A1308, A2531, A3446. A3417, A3548, 2026, A2759, A2003, A1454, A3479, A3297, A3321, A3320, A2952, A3361, A3362, A3394, A3478, A3447, A2004B, A2994, A3404, A1456, A3409, A2862, A2863, A2857, A2860, A3452, A3319, A3344, A3401, A3483, A3450, A3475, A2490, A1450, A2395, A2840, A2955, A3405, A3296, A2951, A3311, A3318, A3448, A3662, A3772, A1457, A3476, A3667, A3783, A3927, A2337.

C) A1323, A1413, A1088, A1821, A1336, A1633, A1276, A1315, A1102. A1850, A1858, A1105, A1510, A1395, A1870, A1866, A1856, A1846, A1869, A1474, A1103, A1113, A1839, A1108, A1290, A1861, A1265, A1278, A1672, A1630, A1198, A1770.

Reason for Recall

Manufacturer has found an issue when using the akima method of calculating the standard curve. A change to the standard curve method for this assay is needed.

Manufacturer

Varian Medical Systems, Inc.

Recall Posting Date

2005-08-08

Trade Name

Multileaf Collimater (MLC)+Software

Recall Start Date

2005-07-01

Recall Number

28682

Hazard Classification

Type II

Model or Catalog #

N

Lot or Serial #

H520003-H520943
H530012-H534223
H540381-H549004

Reason for Recall

Potential mistreatment may occur because initial MLC shape may be an open field and not match planned MLC field when executing dynamic MLC treatment types.

Manufacturer

Zimmer Orthopaedic Surgical Products

Recall Posting Date

2005-07-11

Trade Name

Disposable Tourniquet Cuffs

Recall Start Date

2005-03-10

Recall Number

28499

Hazard Classification

Type II

Model or Catalog #

60707000100, 60707000300, 60707000400, 60707000500, 60707000600

Lot or Serial #

60154121, 60171346, 60162824, 60171348, 60180450, 60171347, 60173808, 60194151, 60194152, 60188441, 60184634, 60202399, 60205580, 60208192, 60176164

Reason for Recall

Some units manufactured with a lower separation strength for the port-to-tube connection. The port