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Terminated

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

FDA Recall Z-1044-2010 · Posted 2010-03-10

Recalling FirmMillipore Corporation
Recall StatusTerminated
Product CodeBSN
Date Initiated2009-11-25
Date Terminated2011-05-23
Product Quantity539 Boxes - 50 per box

Reason for Recall

Membrane integrity defects may allow the passage of viable or non-viable contaminants to pass through the filter.

Firm 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.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution -- United States, Japan and Hungary.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023892MILLEX VV, GV, AND HV SYRINGE FILTER UNITSMillipore Corp. · 2003-01-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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