| Class 1 Device Recall Bard | |
Date Initiated by Firm | December 22, 2005 |
Date Posted | February 22, 2006 |
Recall Status1 |
Completed |
Recall Number | Z-0761-06 |
Recall Event ID |
34393 |
Product Classification |
Hernia repair device - Product Code FTL
|
Product | Bard Composix Kugel Large Circle, 4.5'' for hernia repairs
Product Code: 0010204 |
Code Information |
Lot Numbers: 41*L****, 41*M****, 41*N**** 43*L****, 43*M****, 43*N**** |
Recalling Firm/ Manufacturer |
Davol, Inc., Sub. C. R. Bard, Inc. 100 Sockanossett Crossroad Cranston RI 02920
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For Additional Information Contact | Robin Drago 401-463-7000 Ext. 2389 |
Manufacturer Reason for Recall | Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula. (Extension of recall Z-0524/0526-06) |
FDA Determined Cause 2 | Other |
Action | Davol Inc. notified US Customers by letter on 12/27/05 via Federal Express. Bard Regulatory International was notified 12/22/05 to recall to accounts outside the US. Accounts are requested to return recalled product. A second letter issued dated January 5, 2006 to include additional product codes not identified in the first letter, specifically to the accounts that received those lots.
On 3/24 / 06, Davol issued a third Recall Notification for the extended recall to Hospitals and Distributors and a Dear Doctor Letter to Chief of Surgery. |
Quantity in Commerce | 21,547 |
Distribution | Nationwide
Foreign: Australia, Canada, Japan, |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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