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.
This recall has been terminated (originally issued May 26, 2009).
- Company
- Alcon Laboratories, Inc
- Recall Initiated
- April 29, 2009
- Posted
- May 26, 2009
- Terminated
- October 14, 2009
- Recall Number
- Z-1644-2009
- Quantity
- 59 surgical paks.
- Firm Location
- Worth, TX
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution -- USA and Canada.
Lot / Code Info
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).
Root 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.