FDA-Device2021-05-19Class II
Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.
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.
Sold states
US Nationwide distribution in the states of IL, CT, VA, NM, NY, SC, NJ, OK, MN, MI, NC, OH, AZ, WI, CA, PA, ID.
Affected count
225 boxes of 30 devices
Manufactured in
Kraftgatan 8, Horby, Sweden
Products
Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1548-2021Don't want to check this manually?
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