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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 Recall
CustomPak Surgical Packs
see related information
Date Posted March 01, 2007
Recall Status1 Terminated on June 06, 2007
Recall Number Z-0563-2007
Recall Event ID 37153
Product Classification Knife, Ophthalmic - Product Code HNN
Product Alcon Custom-Pak®, part #6515-51, 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 #633317H, 645074H, and 629784H.
Recalling Firm/
Manufacturer
Alcon Laboratories, Inc
9965 Buffalo Speedway
Houston, Texas 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.
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 30 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
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