Recall Z-0263-2008 ยท FMF Syringe, Piston
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
| Date | Nov 24, 2007 (initiated Oct 25, 2007) |
| Status | Terminated |
| 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) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020666 | DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML Baxter Healthcare Corp, Jun 24, 2002 |