Z-0263-2008

Baxter Duploject Easy Prep, Fibrin Sealant Preparation and Application System ISO; Product Codes: 1500949...

Name: Z-0263-2008 Baxter Duploject Easy Prep, Fibrin Sealant Preparation and Application System ISO; Product Codes: 1500949...
Creator: Baxter Bioscience
Published: 2007-10-25
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2007-10-25 / Terminated / root cause: packaging

FDA source

Baxter Bioscience began a recall of Baxter Duploject Easy Prep, Fibrin Sealant Preparation and Application System ISO; Product Codes: 1500949, 1500950, 1500951, 1501250 & 1501252, Baxter... on 2007-10-25. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0263-2008
Status: Terminated
Initiated: 2007-10-25
Posted: 2007-11-24
Terminated: 2009-03-13
Recalling firm: Baxter Healthcare Corporation
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
Product code: FMF Syringe, Piston
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.
Root cause tag: packaging
FDA root cause: 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)
Product codes and lots: Product Codes: 1500949, 1500950, 1500951, 1501250 & 1501252; Lot Numbers: 07B069, 07B070, 07B071, 07G025 & 07E026

Product code FMF

K020666Class IIDuploject Easy-Prep System 1Ml, 2Ml, 5MlBaxter Healthcare Corp / cleared 2002-06-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)