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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Baxter Duploject Easy Prep		see related information
Date Posted November 24, 2007
Recall Number Z-0263-2008
Product Baxter Duploject Easy Prep, Fibrin Sealant Preparation and Application System ISO; Product Codes: 1500949, 1500950, 1500951, 1501250 & 1501252, Baxter Healthcare Corporation, Deerfield, IL 60015
Code Information Product Codes: 1500949, 1500950, 1500951, 1501250 & 1501252; Lot Numbers: 07B069, 07B070, 07B071, 07G025 & 07E026
Recalling Firm/
Manufacturer		 Baxter Bioscience
1 Baxter Way
Westlake Village, California 91362-3811
For Additional Information Contact Ingrid Anthony-Fausset
805-372-3247
Reason for
Recall		 Sterility (package integrity) compromised: This recall is being conducted due to incomplete seal of the product package at the corner of the outer tray and tyvek lid.
Action An Urgent Product Recall Letter dated October 24, 2007, was issued with attached Product Recall Instructions and Customer Response forms to all consignees (Director of Materials Management, and Director of Risk Management). The recall letter requests sub recalls to the retail level and product quarantine and return. The recall notification letters were sent via commercial carrier (UPS Next Day Service).
Quantity in Commerce 4,782 units (6 units/case)
Distribution Worldwide-USA, Canada and European Union (France and UK)
 
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