Recalling Firm / Manufacturer

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

Code Information

Product Codes: 1500949, 1500950, 1500951, 1501250 & 1501252; Lot Numbers: 07B069, 07B070, 07B071, 07G025 & 07E026

Reason of 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.

Date Recall Initiated

October 25, 2007

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).

Contact

Arabian Health Care Supply Co.(AHCSC)
Riyadh
(01) 4747444

Source of Information

U.S.FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.