Z-0576-04

Millex GS- Syringe Filter 0.22um, Sterile Catalog Number: SLGS033SS

Name: Z-0576-04 Millex GS- Syringe Filter 0.22um, Sterile Catalog Number: SLGS033SS
Creator: Millipore Corp.
Published: 2004-01-26
License: https://open.fda.gov/license/

EMD Millipore Corporation / initiated 2004-01-26 / Terminated / root cause: sterility

FDA source

Millipore Corp. began a recall of Millex GS- Syringe Filter 0.22um, Sterile Catalog Number: SLGS033SS on 2004-01-26. The reason FDA records is "Lack of assurance of sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0576-04
Status: Terminated
Initiated: 2004-01-26
Posted: 2004-07-20
Terminated: 2015-06-11
Recalling firm: EMD Millipore Corporation
Product: Millex GS- Syringe Filter 0.22um, Sterile Catalog Number: SLGS033SS
Product code: FPB Filter, Infusion Line
Reason for recall: Lack of assurance of sterility
Root cause tag: sterility
FDA root cause: Other
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
Product codes and lots: Lot Numbers: F2JN63560 F2KN78263 F2MN78127 F2NN78129 F2NN86699 F2PN69885 R3AN96873 R3AN96873Q R3AN97497 R3AN97497Q R3DN04753 R3DN04754 R3HN06269 R3HN06271 R3HN06272 R3HN89115 R3HN89117 R3JN94935 R3JN94936 R3JN94938 R3JN94940

Product code FPB

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)