Baxter Duploject Easy Prep, Fibrin Sealant Preparation and Application System ISO; Product Codes: 1500949, 1500950, 1500
FDA device recall Z-0263-2008 · posted 2007-11-24 · Terminated
Recall details
- Recalling firm
- Baxter Bioscience
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- FMF
- Quantity affected
- 4,782 units (6 units/case)
- Distribution
- Worldwide-USA, Canada and European Union (France and UK)
- Date initiated
- 2007-10-25
- Date posted
- 2007-11-24
- Date terminated
- 2009-03-13
- Location
- Westlake Village, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML (K020666) | Baxter Healthcare Corp | 2002-06-24 |