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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter Duploject Easy Prep

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  Class 2 Device Recall Baxter Duploject Easy Prep see related information
Date Initiated by Firm October 25, 2007
Date Posted November 24, 2007
Recall Status1 Terminated 3 on March 13, 2009
Recall Number Z-0263-2008
Recall Event ID 45489
510(K)Number K020666  
Product Classification Fibrin Sealant Preparation - Product Code FMF
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 CA 91362-3811
For Additional Information Contact Ingrid Anthony-Fausset
805-372-3247
Manufacturer 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.
FDA Determined
Cause 2		 Packaging process control
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)
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 = FMF and Original Applicant = BAXTER HEALTHCARE CORP.
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