| Date Initiated by Firm | May 05, 2004 |
|---|
| Date Posted | July 20, 2004 |
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| Recall Status1 |
Terminated 3 on November 15, 2006 |
| Recall Number | Z-0960-04 |
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| Recall Event ID |
28998 |
| 510(K)Number | K013860 |
|---|
| Product Classification |
Staple, Implantable - Product Code GDW
|
| Product | Auto SutureTA 30 Reloadable Stapler,Single Patient Use, 4.8mm DST Series
Ref: TA30348S |
|---|
| Code Information |
LOT# P2J506 P2J508 P2K1032 P2K186 P2K614 P2L333 P2M236 P2M549 P2M550 P2M703 P3A1149 P3A1150 P3A453 P3B340 P3C803 P3D86 P3E234 P3E296 P3G10 P3H287 P3H639 P3J245 P3J458 P3K10 P3K11 P3L1009 P3L1010 P3L1131 P3L1132 P3L233 P3L234 P3L43 P3L443 P3L445 P3L446 P3L727 P3L87 P3M366 P3M367 P3M550 P4B161 U2H01 U2H09 |
Recalling Firm/
Manufacturer |
United States Surgical
195 Mcdermott Rd
North Haven CT 06473-3665
|
| For Additional Information Contact | Garry Raymond
203-492-8165 |
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Manufacturer Reason
for Recall | Stapler may clamp without the staples being fired into the tissue |
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FDA Determined
Cause 2 | Other |
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| Action | United States Surgical notiied direct accounts by letter dated 5/5/04. Accounts are requested to inventory and quarantine product for return to USS. |
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| Distribution | Nationwide |
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| 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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = GDW
|
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