Health Canada
www.hc-sc.gc.ca
Common menu bar links
Institutional links
Important Safety Information on the recall of the Mallinckrodt Satin-Slip Intubating Stylet - 6 FR - Notice to Hospitals
Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.
(PDF Version - 609 K)Contact : MHPD-DPSC
The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
This is duplicated text of a letter from Tyco Healthcare Canada. Contact the company for a copy of any references, attachments or enclosures.
NOTICE TO HOSPITALS - Health Canada Endorsed Important Safety Information on the recall of the Mallinckrodt Satin-Slip Intubating Stylet - 6 FR
July 18, 2006
URGENT: MEDICAL DEVICE RECALL - PRIORITY 1
To: Director, Purchasing / Materials Management
From: Tyco Healthcare Canada - Regulatory Affairs Department
Subject: VOLUNTARY PRODUCT RECALL - MALLINCKRODT® SATIN-SLIP® INTUBATING STYLET - 6 FR, Order code: 85863
Dear Valued Customer:
This letter is to inform you that Tyco Healthcare / Nellcor recently received a number of reports regarding the plastic sheath material separating from Mallinckrodt Satin-Slip Intubating Stylets, size 6 Fr., item number 85863. While the rate of this occurrence is low, if sheath separation occurs, the sheath material may become lodged in the patient's endotracheal tube or respiratory tract, requiring medical intervention. While we investigate the root cause of the sheath material separation, we have elected to recall all size 6 Fr. Satin-Slip Intubating Stylets, item number 85863, with lot numbers beginning with the numbers 05 or 06.
We recommend that your facility immediately cease use of the 6 Fr. Satin-Slip Intubating Stylet, item number 85863, with lot numbers beginning with 05 or 06, and remove all such product from your facility's inventory.
Please follow these 3 important steps:
- Complete the attached Customer Response Form as soon as possible. Regardless of whether or not you have affected inventory, regulatory requirements necessitate the completion of the Customer Response Form and faxing to our Regulatory Affairs Dept. at: fax 1-514-695-1889.
- If you do have affected product, in addition to step 1; please call our Customer Service Department at 1-877-664-8926 press #1, with your original PO number to obtain a Return Authorization Number. This will facilitate an immediate return for credit.
- If you do not have any affected product, please complete the Customer Response Form and return it to the Regulatory Affairs Dept. as soon as possible via fax 1-514-695-1889.
It is important to note that 10 Fr. And 14 Fr. sizes of the Satin-Slip Intubating Stylet are not affected by this action. Please note, as discussed in the Mallinckrodt Satin-Slip Intubating Stylet Directions for Use, all sizes of Mallinckrodt Satin-Slip Intubating Stylets are single-patient use devices, and should be discarded following single use. Do not attempt to re-use any size of Mallinckrodt Satin-Slip Intubating Stylets.
DISTRIBUTORS: If you or your facility has distributed the 6 Fr. Satin-Slip Intubating Stylet to other persons or facilities, please promptly contact the recipients of the devices and provide them with the information regarding this action. Regulatory regulations necessitate the tracking of said notification with a summary of your actions to the undersigned at Tyco Healthcare Canada.
As we are actively investigating this matter, we can not predict when we expect to have the 6 Fr. Satin-Slip Intubating Stylet available. We are committed to providing you and your patient with the highest quality products and services and apologize for the inconvenience that this matter may cause. Your response is vital to our ability to monitor the effectiveness of this voluntary recall. Thank you for your support of Tyco Healthcare / Nellcor products. Health Canada has been advised of this action. Please contact us should you have any additional questions or requests for further assistance with this process.
Tyco Healthcare Canada
7500 Trans Canada Highway
Pointe Claire, Quebec
H9R 5H8
Tel. 1-877-664-8926
Any suspected adverse incident can also be reported to:
Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Tel: The Inspectorate Hotline 1-800-267-9675
The Reporting Form and Guidelines can be obtained from the Health Canada web site.
For other inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: MHPD_DPSC@hc-sc.gc.ca
Tel: (613) 954-6522
Fax: (613) 952-7738
Sincerely,
original signed by
Dawn Boyce
Senior Quality Assurance Analyst
cc:
C. Maloin
E. Hrimech
M. Jacques
F. Drolet
G. Emond
I. Voisard
J. Porter
A. St-Amant
J. Di Marzo
R. Catracchia
CUSTOMER RESPONSE FORM - PRIORITY 1 RECALL
MALLINCKRODT® SATIN-SLIP® INTUBATING STYLET - 6 FR, Order code: 85863
The following information must be completed and faxed to:
Tyco Healthcare Canada,
Dawn Boyce, Regulatory Dept.
Fax: 1-514-695-1889
Please indicate as applicable:
We have no affected product in stock.
We have the following affected product in stock and have contacted
Tyco Healthcare Canada - Customer Service to arrange for return.
CATALOGUE NUMBER
LOT NUMBER
QTY IN STOCK (EACH)
Hospital Name:
Address:
City, Province:
Signature:
Date:
Printed Name:
Title / Department:
Phone Number:
