Atos Medical AB recalls Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients brea…
- Recall date
- March 29, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1548-2021
- FDA classification
- Class II
- Brand / firm
- Atos Medical AB
- Sold / distributed
- US Nationwide distribution in the states of IL, CT, VA, NM, NY, SC, NJ, OK, MN, MI, NC, OH, AZ, WI, CA, PA, ID.
Why it was recalled
Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.
Get recall alerts
Free email alert whenever Atos Medical AB has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Atos Medical AB