Recall Z-1643-2009
Alcon Laboratories, Inc · initiated April 29, 2009
Product
Alcon 25 GA Total Plus Pak, Catalog/Item #8065750220; for use with ACCURUS Vitrectomy System; distributed by Alcon Laboratories, Inc., Fort Worth, TX 76134.
Codes / lots: Lot #9013991X, 9014291X and 9014509X.
Reason for recall
Specific lots of Alcon 25 GA Trocar Blades do not conform to finished product specifications in that oxidation can occur on some of the blades.
FDA-determined cause: Process control
Action taken
Firm began notifying consignees of recall by Urgent: Medical Device Recall letter on 04/29/09 (letters sent via FedEx). Consignees instructed to check inventory for affected lots; to complete and return the Medical Device Recall Response Form; to contact Alcon to arrange for return of the devices; that credit will be issued for the recalled product when it is returned; and in the case that there is no inventory remaining, to indicate that on the Response Form and return it as well. Consignees should contact Alcon Technical Consumer Affairs at 1-800-561-6466, Option 8 for technical assistance.
Details
- Recall number
- Z-1643-2009
- Initiated
- April 29, 2009
- Posted by FDA
- May 26, 2009
- Terminated
- October 14, 2009
- Product code
- NGY – Cannula, Trocar, Ophthalmic
- Quantity
- 3,523 surgical paks.
- Distribution
- Worldwide Distribution -- USA and Canada.
- Recalling firm
- Alcon Laboratories, Inc, Fort Worth, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1644-2009 | Alcon Vitrectomy 25 GA Custom Pak, Catalog/Item #10240-03, 11077-03, 11187-02 and…Specific lots of Alcon 25 GA Trocar Blades do not conform to finished product specifications in that… | 04/29/2009Terminated |