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Health Canada Endorsed Important Safety Information on Weck brand ligating clips
Subject: Urgent Medical Device Recall - First Notice
Dear Valued Teleflex Medical Customer:
Teleflex Medical has issued a voluntary recall for Weck brand ligating clips including Hem-O-Lok, Horizon, Hemoclip Traditional and Hemoclip Plus products because holes were detected in the thermoformed tray of certain sterile packaged units meaning the sterile integrity cannot be guaranteed.
Based on Teleflex Medical product inspections, we have identified 317 breaches in approximately 1,478,631 packages inspected (frequency of occurrence = 0.0214 percent). The scope of the recall includes catalog numbers which are identified in the attached table that were manufactured between January 2006 through July 2008. Product with a manufacturing date of August 2008 and beyond is not a part of this recall. Health Canada has been notified of this action.
Products affected by this recall:
Attachment A provides a listing of all identified product codes and description.
For a listing of all identified product codes with their associated lot numbers that are affected by this recall, please contact Pulling Weck Canada (Customer Service 1-800-387-9699).
Our records indicate that the product included in the scope of this recall has been distributed in Canada. Teleflex Medical is aware that Health Canada will post this recall letter on the Health Canada website. In order to provide the highest level of quality product to our customers, we are notifying our customers to take the following actions:
Cease use and distribution and quarantine all affected product immediately.
Complete the enclosed Acknowledgment Form & Stock Status Form for the above identified product(s), sign the form and immediately fax back to PILLING WECK CANADA, Attention: Recalls 1-905-943-9001. This will allow confirmation of your receipt of this notification and the amount of product you have on hand for return.
If you have affected product in stock, return it to Teleflex Medical, Recalled Product, Attention: Pilling Weck Canada, 1-165 Gibson Drive, Markham, Ontario L3R 3K7. Charge the shipping of the returned product to the Teleflex Medical recall Purolator Account #1-1161379. Choose "Purolator-Ground" as the method of shipment and enclose a copy of your Acknowledgement Form with the returned product.
If you are a distributor, communicate the recall notice to your customers who received product in the scope of the recall by providing a copy of this recall notification to them. Also, provide a copy of the Acknowledgement Form. This form should be completed in its entirety, signed and returned by mail or FAX to: Pilling Weck Canada, Attention: Recall Department (FAX number: 905 943-9001). Customers must return all affected product in their possession and charge the shipping by GROUND to the Teleflex Medical recall Purolator Account #1-1161379.
Teleflex Medical can credit your account when the product is returned. In order to facilitate your credit please provide the following information: Pilling Weck Customer Account Number, PO Number or Invoice Number.
We apologize for any inconvenience this may have caused. If you require additional information or clarification regarding this matter, please contact Customer Service at 1-800-387-9699 ; 905- 943-9000, or your Local Sales Representative at the following numbers:
Gary MacKenzie (Atlantic Canada) 1-902-441-8430
Gilbert Boucher (Quebec, Quebec) 1-418-956-1193
Rejean Wolfe (Montreal, Quebec) 1-514-994-4761
Jane Enright (Ottawa, Toronto, Hamilton, Niagara) 1-416-540-7916
Jeff Kutchma (Ontario East, North) 1-416-707-1074
Greg Goldsmith (South West Ontario, Manitoba) 1-519-319-6544
Paul Riddoch (Alberta, Saskatchewan) 1-403-714-8696
Kevin Alkema (British Columbia) 1-604-807-8836
PILLING WECK CANADA is in the process of inspecting all of our Canadian Inventory. 100% of this inventory will be inspected before it is released for sale. The inspected product will be marked with a YELLOW STICKER on each Cartridge and on each BOX. This clearly identifies product that has been inspected for holes in the hard plastic tray that encloses these affected ligation clips. If you have any of this marked product in inventory you need not return it.
Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious or unexpected adverse incidents in patients using Weck Brand Ligating Clips should be reported to Teleflex Medical or Health Canada at the following addresses:
Teleflex Medical
Pilling Weck Canada
1-165 Gibson Drive
Markham (Ontario) L3R 3K7
Telephone: 800-387-9699
Fax: 905-943-9001
Any suspected adverse incident can also be reported to:
Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Telephone: The Inspectorate Hotline 1-800-267-9675
The Medical Devices Problem Report Form and Guidelines can be found on 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
Telephone: 613-954-6522
Fax: 613-952-7738
ATTACHMENT A – Listing of all identified Product codes / Description affected by this recall.
HORIZON
001200 - HORIZON SMALL TI 6 CLIP
001201 - HORIZON SMALL RED TI 6 CLIP WIDE SLOT
002200 - HORIZON MED TI CLIP
003200 - HORIZON MED/LRG TI 6 CLIP
004200 - HORIZON LARGE TI 6 CLIP
005200 - HORIZON MICRO TI 6 CLIP/CART 30 CART/BOX
HEM-O-LOK
544220 - Hem-o-Lok M Non Absorbable Polymer Clips
544230 - Hem-o-Lok ML Non Absorbable Polymer Clips
544240 - Hem-o-Lok L Non Absorbable Polymer Clips
544250 - Hem-o-Lok XL Non Absorbable Polymer Clips
HEMOCLIP AUTO
527100 - HEMOCLIP AUTO S/S MEDIUM 200/BOX
HEMOCLIP TRADITIONAL
523700 - HEMOCLIP TITANIUM MEDIUM 250/BOX
523735 - HEMOCLIP TITANIUM SMALL 300/BOX
523760 - HEMOCLIP TITANIUM MEDIUM-LARGE 200/BOX
523770 - HEMOCLIP TITANIUM LARGE 150/BOX
523800 - HEMOCLIP TITANIUM MEDIUM 200/BOX
523835 - HEMOCLIP TITANIUM SMALL 240/BOX
523860 - HEMOCLIP TITANIUM MEDIUM-LARGE 160/BOX
523870 - HEMOCLIP TITANIUM LARGE 120/BOX
HEMOCLIP PLUS
533700 - HEMO PLUS TITANIUM MEDIUM 25CLIP/10CART
533735 - HEMO PLUS TITANIUM SMALL 25CLIP/12CART
533737 - HEMO PLUS TI 25/CART 300BOX NO TAPE
533802 - HEMO PLUS TI M10/18CART NO TAPE
533837 - HEMO PLUS TI S10/18CART NO TAPE
533862 - HEMO PLUS TI ML10/12CART NO TAPE
533872 - HEMO PLUS TI L10/12CART NO TAPE
534735 - HEMO PLUS STRGPT TI SM25/CART 300/BOX
534737 - HEMO PLUS STRONGPOINT SM NOTAPE 300 25
534837 - HEMO PLUS STRONGPOINT SM NO TAPE 180 10
Acknowledgment Form
Immediate Attention Requested
Please check the appropriate box and return this form by FAX to 905-943-9001 immediately:
We have no inventory within the scope of this recall.
We have the following affected product at our facility. We have discontinued use and quarantined the affected product.
QUANTITY -
CATALOG NUMBER -
LOT NUMBER -
Return all affected product to:
PILLING WECK CANADA
Recalled Product
Attention: Recall Department
1-165 Gibson Drive, Markham
Ontario, L3R 3K7 |