Important Safety Information on the recall of Adult Respiratory Ventilator Circuits

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Contact : MHPD-DPSC

Health Canada Endorsed Important Safety Information on the recall of Adult Respiratory Ventilator Circuits (RT110, RT111, RT210, RT211 Lots Ranging from 041101 through 050331 (inclusive))

December 28, 2005

Dear Source Medical and Cardinal Health customer,

Fisher & Paykel Healthcare has notified us of the recall of the specific circuits and lot numbers referenced above, due to potential insulation damage to the heater wires. Please review the enclosed Fisher & Paykel recall letter for more details.

The affected lot numbers were manufactured between November 1, 2004 and March 31, 2005. Our distribution records indicate that you may have received affected circuits during this time.

Therefore, please take the following steps:

Source Medical will forward the completed Customer Reply forms to Fisher & Paykel, who will ship replacement product directly to your facility if required.

If you have any questions, please contact your Cardinal Health Respiratory Therapy Specialist, or contact Kristina Buzadzija at 1-888-871-5945 ext, 5140.

Sincerely,

original signed by

Angela Stanley
Q.A. Compliance Specialist
Source Medical and Cardinal Health

Encl: Customer Reply form
Fisher & Paykel Dec. 21, 2005 Recall Letter

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CUSTOMER REPLY

To: Angela Stanley, Quality Assurance
Company: Source Medical
Fax: (416) 213-5019
Phone: 1-888-871-5945; (416) 213-5105

Hospital/Customer:
Customer Number:
Address:
City/Province:

Comments: Product Recall, RT110, RT111, RT210, RT211, lot range from 041101 through 050331 (inclusive), ref. 2005FCA44

I,(PLEASE PRINT), have received and acknowledge the details outlined in this letter.

TITLE :
SIGNATURE :
DATE :
PHONE#:

WE HAVE INSPECTED OUR INVENTORY AND HAVE NO AFFECTED STOCK OF THESE PRODUCTS.

WE HAVE THE FOLLOWING STOCK FROM THE AFFECTED LOT RANGE 041101 THROUGH 050331, AND HAVE DESTROYED IT AS PER INSTRUCTIONS. (Fisher & Paykel will issue replacement based on this information)

RT110
QUANTITY: EA./BX.

RT111
QUANTITY: EA./BX.

RT210
QUANTITY: EA./BX.

RT211
QUANTITY: EA./BX.
(1 BOX = 10 CIRCUITS)

2005FCA44

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Fisher & Paykel Healthcare Limited
15 Maurice Paykel Place, East Tamaki
P O Box 14 348, Panmure
Auckland, New Zealand
Telephone: +64 9 574 0100
Facsimile: +64 9 574 0158
Website: www.fphcare.com

21 December 2005

FILE REF: 2005 Adult Circuit Recall Letter Canada

Dear Sir/Madam,

Notice of Recall - Fisher & Paykel Healthcare Adult Respiratory Ventilator Circuit -
Dual Heated

Fisher & Paykel Healthcare has initiated a voluntary recall for adult breathing circuits that contain a spiral expiratory heater wire.

It has been identified that the manufacturing process of the Adult respiratory ventilator circuit - dual heated, may have had the potential to damage the insulation of the heater wire in circuits within a specified lot range. This may lead to a potential risk of fire in some circumstances.

This recall affects ONLY adult breathing circuits with a spiral wound, expiratory heater wire manufactured by Fisher & Paykel Healthcare. The following circuits are NOT affected: EVAQUA™, single-limb heated circuits, and neonatal circuits.

The affected catalog numbers are:

Canada: RT110, RT111, RT210, RT211

The affected lot codes are:

041101 to 050331 (inclusive).
Stock manufactured between 1 November 2004 and 31 March 2005.

Please check your stock of Fisher & Paykel Healthcare dual-heated, adult breathing circuits for any stock in the affected lot range, and destroy any stock you may have in that lot range. Please contact all your customers with this information and request they acknowledge this action and they destroy all stock.

In addition, Fisher & Paykel Healthcare wishes to take this opportunity to advise you that the labelling for the catalog numbers listed in this recall letter will be modified in the future to introduce a recommendation of a maximum 7 day use.

We apologise for any inconvenience this recall will cause. Please contact us if further details or clarification is required.

Yours sincerely

original signed by

Adele Bindon
Regulatory Affairs Manager - Intensive Care
Fisher & Paykel Healthcare Limited
Ph: + 64 9 574 0123, ext. 8813
Fax: + 64 9 574 0158
Email: Adele.Bindon@fphcare.co.nz

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Urgent: Device Recall Response Form

Please return this form by fax or post to the fax number listed below.

NOTE: A response is required even if you have no stock in the affected lot range.

I,PLEASE PRINT, have received and acknowledge the details outlined in this letter.

Please indicate the amount of stock in your distribution in the affected lot range (041101 to 050331, inclusive) and the amount destroyed in the table below:

Catalog Number
Number in stock
Number in stock

RT110
RT111
RT210
RT211

Please note, 1 box = 10 circuits.

Signature:
Name: PLEASE PRINT
Position:
Hospital:
Date: