Date Initiated by Firm | April 29, 2009 |
Date Posted | May 26, 2009 |
Recall Status1 |
Terminated 3 on October 14, 2009 |
Recall Number | Z-1644-2009 |
Recall Event ID |
51964 |
510(K)Number | K880961 |
Product Classification |
Ophthalmic Trocar Cannula - Product Code NGY
|
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. |
Code Information |
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). |
Recalling Firm/ Manufacturer |
Alcon Laboratories, Inc 6201 South Fwy Fort Worth TX 76134
|
For Additional Information Contact | 817-551-6813 |
Manufacturer 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 2 | Process control |
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. |
Quantity in Commerce | 59 surgical paks. |
Distribution | Worldwide Distribution -- USA and Canada. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = NGY
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