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Atos Medical AB recalls Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients brea
Recalled May 19, 2021 · FDA recall Z-1548-2021 · Atos Medical AB
Hazard
Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma. · FDA Class II
Units
225 boxes of 30 devices
Sold at
US Nationwide distribution in the states of IL, CT, VA, NM, NY, SC, NJ, OK, MN, MI, NC, OH, AZ, WI, CA, PA, ID.
Description
Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma.
Product
Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.
Manufacturer(s)
Atos Medical AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →