FDA Medical Device Recalls (openFDA)
Smiths Medical International Ltd: Portex HEPA Bacterial /Viral Filter, Non-Latex Ref: 002890
- Recall number
- Z-0961-05
- Recalling firm
- Smiths Medical International Ltd
- Product
- Portex HEPA Bacterial /Viral Filter, Non-Latex Ref: 002890
- Status
- Terminated
- Initiated
- 2005-06-07
- Posted
- 2005-07-07
- Terminated
- 2012-05-08
- Reason
- Mislabeled: The package contains a Heat and Moisture (HME) filter instead of a HEPA filter stated on the product label
- 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
- 292 units
- Distribution
- CA, NJ, PA, WV
- Lot, serial or model codes
- Lot Number: 634418
- 510(k) numbers
- ["K930816"]
- PMA numbers
- not on file
- Product code
- CAH
- Firm FEI
- 3002807908
- Firm city
- Hythe
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28