Alcon Vitrectomy 25 GA Custom Pak, Catalog/Item #10240-03, 11077-03, 11187-02 and 13305-01; distributed by Alcon Laborat
FDA device recall Z-1644-2009 · posted 2009-05-26 · Terminated
Recall details
- Recalling firm
- Alcon Laboratories, Inc
- 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.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NGY
- Quantity affected
- 59 surgical paks.
- Distribution
- Worldwide Distribution -- USA and Canada.
- Date initiated
- 2009-04-29
- Date posted
- 2009-05-26
- Date terminated
- 2009-10-14
- Location
- Fort Worth, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALCON SURGICAL PROCEDURE PACKS (K880961) | Alcon Laboratories | 1988-04-29 |