Baxter Duploject Easy Prep, Fibrin Sealant Preparation and Application System ISO; Product Codes: 1500949, 1500950, 1500951, 1501250 & 1501252, Baxter Healthcare Corporation, Deerfield, IL 60015
FDA Recall Z-0263-2008 · Posted 2007-11-24
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Recalling FirmBaxter Bioscience
Recall StatusTerminated
Product CodeFMF
Date Initiated2007-10-25
Date Terminated2009-03-13
Product Quantity4,782 units (6 units/case)
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.
Firm 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).
Root Cause
Packaging process control
Distribution Pattern
Worldwide-USA, Canada and European Union (France and UK)
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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