FDA recall Z-1548-2021

Atos Medical AB · Class II · device

Product

Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.

Reason for recall

Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma.

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.

Key facts

Status
Terminated
Initiation date
2021-03-29
Report date
2021-05-19
Termination date
2022-02-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Horby, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1548-2021