FDA Medical Device Recalls (openFDA)
Baxter Bioscience: Baxter Duploject Easy Prep, Fibrin Sealant Preparation and Application System ISO; Product Codes: 1500949, 1500950, 1500951, 1501250 & 1501252, Baxter Healthcare Corporation, Deerfield, IL 60015
- Recall number
- Z-0263-2008
- Recalling firm
- Baxter Bioscience
- 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
- Status
- Terminated
- Initiated
- 2007-10-25
- Posted
- 2007-11-24
- Terminated
- 2009-03-13
- Reason
- 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
- 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
- 4,782 units (6 units/case)
- Distribution
- Worldwide-USA, Canada and European Union (France and UK)
- Lot, serial or model codes
- Product Codes: 1500949, 1500950, 1500951, 1501250 & 1501252; Lot Numbers: 07B069, 07B070, 07B071, 07G025 & 07E026
- 510(k) numbers
- ["K020666"]
- PMA numbers
- not on file
- Product code
- FMF
- Firm FEI
- 1417572
- Firm city
- Westlake Village
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28