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U.S. Department of Health and Human Services

Class 2 Device Recall CustomPak Surgical Packs

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  Class 2 Device Recall CustomPak Surgical Packs see related information
Date Initiated by Firm December 22, 2006
Date Posted March 01, 2007
Recall Status1 Terminated 3 on June 06, 2007
Recall Number Z-0561-2007
Recall Event ID 37153
Product Classification Surgical Packs - Product Code HNN
Product Alcon Custom-Pak¿, part #2638-17, containing BD Beaver¿ Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.
Code Information Lot #627618H and 636380H.
Recalling Firm/
Manufacturer		 Alcon Laboratories, Inc
9965 Buffalo Speedway
Houston TX 77054-1309
Manufacturer Reason
for Recall		 Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.
FDA Determined
Cause 2		 Other
Action Customers notified of recall via phone on 12/22/06, with follow-up fax and letter. A revised notification was made via phone and fax to each customer on 12/26/06. Customers instructed not to use blades and to return blades for a replacement. Recall to the user/hospital level.
Quantity in Commerce 27 custom surgical packs.
Distribution Custom surgical packs sold to hospitals in AR, MN, NY, TX and WI.
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.
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