FDA Medical Device Recalls (openFDA)
Atos Medical AB: Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.
- Recall number
- Z-1548-2021
- Recalling firm
- Atos Medical AB
- Product
- Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.
- Status
- Terminated
- Initiated
- 2021-03-29
- Posted
- not on file
- Terminated
- 2022-02-17
- Reason
- Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma.
- Root cause
- Device Design
- Action
- Atos Medical initiated the recall by telephone and email on 03/29/2021 to the medical facilities. The firm followed with a letter mailed (USPS) on 04/01/2021. The firm will begin contacting the patients the week of April 5, 2021 to confirm receipt of the letter, confirm understanding of the correct use, and answer any questions.
- Quantity
- 225 boxes of 30 devices
- Distribution
- US Nationwide distribution in the states of IL, CT, VA, NM, NY, SC, NJ, OK, MN, MI, NC, OH, AZ, WI, CA, PA, ID.
- Lot, serial or model codes
- Lot Numbers: 2012158 and 2012124
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BYD
- Firm FEI
- 3002806269
- Firm city
- Horby
- Firm state
- not on file
- Firm country
- Sweden
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