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U.S. Department of Health and Human Services

Class 2 Device Recall Vitrectomy 25G Custom Surgical Pak

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  Class 2 Device Recall Vitrectomy 25G Custom Surgical Pak see related information
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
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.
510(K) Database 510(K)s with Product Code = NGY and Original Applicant = ALCON LABORATORIES
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