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Terminated

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

FDA Recall Z-0961-05 · Posted 2005-07-07

Recalling FirmSmiths Medical International Ltd
Recall StatusTerminated
Product CodeCAH
Date Initiated2005-06-07
Date Terminated2012-05-08
Product Quantity292 units

Reason for Recall

Mislabeled: The package contains a Heat and Moisture (HME) filter instead of a HEPA filter stated on the product label

Firm 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.

Root Cause

Other

Distribution Pattern

CA, NJ, PA, WV

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K930816HEPA FILTERED HMEIntertech Resources, Inc. · 1993-07-01

Official Source

View FDA Recall →

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

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