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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Custom-Pak® Surgical Packs		see related information
Date Posted March 01, 2007
Recall Number Z-0561-2007
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, Texas 77054-1309
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 27 custom surgical packs.
Distribution Custom surgical packs sold to hospitals in AR, MN, NY, TX and WI.
 
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