Z-0961-05

Portex HEPA Bacterial /Viral Filter, Non-Latex Ref: 002890

Name: Z-0961-05 Portex HEPA Bacterial /Viral Filter, Non-Latex Ref: 002890
Creator: Smiths Medical International Ltd
Published: 2005-06-07
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-06-07 / Terminated / root cause: labeling and UDI

FDA source

Smiths Medical International Ltd began a recall of Portex HEPA Bacterial /Viral Filter, Non-Latex Ref: 002890 on 2005-06-07. The reason FDA records is "Mislabeled: The package contains a Heat and Moisture (HME) filter instead of a HEPA filter stated on the product label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0961-05
Status: Terminated
Initiated: 2005-06-07
Posted: 2005-07-07
Terminated: 2012-05-08
Recalling firm: Abbott Medical
Product: Portex HEPA Bacterial /Viral Filter, Non-Latex Ref: 002890
Product code: CAH Filter, Bacterial, Breathing-Circuit
Reason for recall: Mislabeled: The package contains a Heat and Moisture (HME) filter instead of a HEPA filter stated on the product label
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Smiths Medical notified 8 accounts by letter dated June 3, 2005. Distributors are requested to contact accounts end-users (hospitals) . Users are requested to return inventory.
Quantity in commerce: 292 units
Distribution: CA, NJ, PA, WV
Product codes and lots: Lot Number: 634418

Product code CAH

K930816Class IIHepa Filtered HmeIntertech Resources, Inc. / cleared 1993-07-01

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)