Z-0577-04

Millex HA Syringe Filter 0.45um, Sterile Catalog Number: SLHA033SS

Name: Z-0577-04 Millex HA Syringe Filter 0.45um, Sterile Catalog Number: SLHA033SS
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 HA Syringe Filter 0.45um, Sterile Catalog Number: SLHA033SS 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-0577-04
Status: Terminated
Initiated: 2004-01-26
Posted: 2004-07-20
Terminated: 2015-06-11
Recalling firm: EMD Millipore Corporation
Product: Millex HA Syringe Filter 0.45um, Sterile Catalog Number: SLHA033SS
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: 15 boxes ( 50/box)
Distribution: CA, CO, DE, IL, OH, PA, MA, MO, MD, MT, RI, VA Canada
Product codes and lots: Lot Numbers: F2KN69893 F2MN78131 F2NN82062 F2PN78264 R3DN04757 R3DN04758 R3HN06273 R3HN06274 R3HN89112 R3HN89113 R3HN93120 R3JN17305 R3JN25568 R3JN93121 R3KN94945 R3MN58189

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)