Z-1044-2010

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

Name: Z-1044-2010 Millipore Millex Syringe Filter Unit, 33 mm Durapore PVDF 0.22um, Sterile, 50 Filters per box. Catalog...
Creator: Millipore Corporation
Published: 2009-11-25
License: https://open.fda.gov/license/

EMD Millipore Corporation / initiated 2009-11-25 / Terminated / root cause: manufacturing process

FDA source

Millipore Corporation began a recall of Millipore Millex Syringe Filter Unit, 33 mm Durapore PVDF 0.22um, Sterile, 50 Filters per box. Catalog Number: SLGVM33RS on 2009-11-25. The reason FDA records is "Membrane integrity defects may allow the passage of viable or non-viable contaminants to pass through the filter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1044-2010
Status: Terminated
Initiated: 2009-11-25
Posted: 2010-03-10
Terminated: 2011-05-23
Recalling firm: EMD Millipore Corporation
Product: Millipore Millex Syringe Filter Unit, 33 mm Durapore PVDF 0.22um, Sterile, 50 Filters per box. Catalog Number: SLGVM33RS.
Product code: BSN Filter, Conduction, Anesthetic
Reason for recall: Membrane integrity defects may allow the passage of viable or non-viable contaminants to pass through the filter.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Lot/Serial Number: R8PN37631, Exp: 30th Nov 2011

Product code BSN

K023892Class IIMillex Vv, Gv, and Hv Syringe Filter UnitsMillipore Corp. / cleared 2003-01-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)