Recall Z-1644-2009
Alcon Laboratories, Inc · initiated April 29, 2009
Product
Alcon Vitrectomy 25 GA Custom Pak, Catalog/Item #10240-03, 11077-03, 11187-02 and 13305-01; distributed by Alcon Laboratories, Inc., Fort Worth, TX 76134.
Codes / lots: Lot #899513H (for Cat/Item #10240-03), 892675H (for Cat/Item #11077-03), 892670H (for Cat/Item #11187-02) and 894213H (for Cat/Item #13305-01).
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-1644-2009
- Initiated
- April 29, 2009
- Posted by FDA
- May 26, 2009
- Terminated
- October 14, 2009
- Product code
- NGY – Cannula, Trocar, Ophthalmic
- Quantity
- 59 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-1643-2009 | Alcon 25 GA Total Plus Pak, Catalog/Item #8065750220; for use with ACCURUS Vitrectomy…Specific lots of Alcon 25 GA Trocar Blades do not conform to finished product specifications in that… | 04/29/2009Terminated |