Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0573-04

Millex-GS Syringe Filter Unit 0.22 um, Sterile Catalog Number: SLGSM33SS

EMD Millipore Corporation / initiated 2004-01-26 / Terminated / root cause: sterility

Millipore Corp. began a recall of Millex-GS Syringe Filter Unit 0.22 um, Sterile Catalog Number: SLGSM33SS on . The reason FDA records is "Lack of assurance of sterility". As of , the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number
Z-0573-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
EMD Millipore Corporation
Product
Millex-GS Syringe Filter Unit 0.22 um, Sterile Catalog Number: SLGSM33SS
Product code
FPB Filter, Infusion Line
Reason for recall
Lack of assurance of sterility
Root cause tag
sterility
FDA root cause
Other
Action
Millipore notified direct and distributor accounts by Certified letter on 1/26/04. Users are requested to return product. Millipore France and Ireland coordinating recall to the international accounts.
Quantity in commerce
45 boxes ( 50/box)
Distribution
CA, CO, DE, IL, OH, PA, MA, MO, MD, MT, RI, VA Canada
Product codes and lots
Lot Number: F2PN86704