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.
FDA Recall Z-1644-2009 · Posted 2009-05-26
Advertisement
Recalling FirmAlcon Laboratories, Inc
Recall StatusTerminated
Product CodeNGY
Date Initiated2009-04-29
Date Terminated2009-10-14
Product Quantity59 surgical paks.
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.
Firm Action
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
Distribution Pattern
Worldwide Distribution -- USA and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement