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U.S. Department of Health and Human Services

Class 2 Device Recall Millex Syringe Filter Unit

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  Class 2 Device Recall Millex Syringe Filter Unit see related information
Date Initiated by Firm November 25, 2009
Date Posted March 10, 2010
Recall Status1 Terminated 3 on May 23, 2011
Recall Number Z-1044-2010
Recall Event ID 53896
510(K)Number K023892  
Product Classification Filter, conduction, anesthetic - Product Code BSN
Product Millipore Millex Syringe Filter Unit, 33 mm Durapore PVDF 0.22um, Sterile, 50 Filters per box. Catalog Number: SLGVM33RS.





Code Information Lot/Serial Number: R8PN37631, Exp: 30th Nov 2011
Recalling Firm/
Manufacturer		 Millipore Corporation
290 Concord Rd
Billerica MA 01821-3405
Manufacturer Reason
for Recall		 Membrane integrity defects may allow the passage of viable or non-viable contaminants to pass through the filter.
FDA Determined
Cause 2		 Process control
Action Millipore Corporation issued an "Urgent: Medical Device Recall" letter dated November 24, 2009 requesting users to examine inventory and immediately discontinue use and return all affected product to the firm. For further information, contact Millipore Technical Services at 1-800-645-5476.
Quantity in Commerce 539 Boxes - 50 per box
Distribution Worldwide Distribution -- United States, Japan and Hungary.
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.
510(K) Database 510(K)s with Product Code = BSN and Original Applicant = MILLIPORE CORP.
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