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U.S. Department of Health and Human Services

Class 2 Device Recall Millipore

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  Class 2 Device Recall Millipore see related information
Date Initiated by Firm January 26, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on June 11, 2015
Recall Number Z-0573-04
Recall Event ID 28223
Product Classification Filter, Infusion Line - Product Code FPB
Product Millex-GS Syringe Filter Unit 0.22 um, Sterile
Catalog Number: SLGSM33SS
Code Information Lot Number: F2PN86704
Recalling Firm/
Millipore Corp.
80 Ashby Rd
Bedford MA 01730-2237
For Additional Information Contact Thomas Borrows
Manufacturer Reason
for Recall
Lack of assurance of sterility
FDA Determined
Cause 2
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
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.