Class 2 Device Recall Millipore

• Date Initiated by Firm: January 26, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on June 11, 2015
• Recall Number: Z-0575-04
• Recall Event ID: 28223
• Product Classification: Filter, Infusion Line - Product Code FPB
• Product: Millex-AA Syringe Driven Filter 0.8 um, Sterile Catalog Number: SLAAM33SS
• Code Information: Lot Number: F2PN86703
• FEI Number: 1216103
• Recalling Firm/ Manufacturer: Millipore Corp.; 80 Ashby Rd; Bedford MA 01730-2237
• For Additional Information Contact: Thomas Borrows; 781-533-2622
• Manufacturer Reason for Recall: Lack of assurance of sterility
• FDA Determined 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: 1 boxes ( 50/box)
• Distribution: CA, CO, DE, IL, OH, PA, MA, MO, MD, MT, RI, VA Canada
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.