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
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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
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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.
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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 |
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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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510(K) Database | 510(K)s with Product Code = FMF
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