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Millipore Millex Syringe Filter Unit, 33 mm Durapore PVDF 0.22um, Sterile, 50 Filters per box. Catalog Number: SLGVM33RS

FDA device recall Z-1044-2010 · posted 2010-03-10 · Terminated

Recall details

Recalling firm
Millipore Corporation
Reason for recall
Membrane integrity defects may allow the passage of viable or non-viable contaminants to pass through the filter.
Action taken
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.
Root cause
Process control
Status
Terminated
Product code
BSN
Quantity affected
539 Boxes - 50 per box
Distribution
Worldwide Distribution -- United States, Japan and Hungary.
Date initiated
2009-11-25
Date posted
2010-03-10
Date terminated
2011-05-23
Location
Billerica, MA

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Related 510(k) clearances

RecordFirmDate
MILLEX VV, GV, AND HV SYRINGE FILTER UNITS (K023892)Millipore Corp.2003-01-17