Device product
Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.
Z-1548-2021
Product summary
- Firm
- Atos Medical AB
- Event
- Event 87635
- Status
- Terminated
- Classification
- Class II
- Quantity
- 225 boxes of 30 devices
- Official record key
device-enforcement:Z-1548-2021
Official wording
Reason: Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma.
Code information: Lot Numbers: 2012158 and 2012124
Distribution pattern: US Nationwide distribution in the states of IL, CT, VA, NM, NY, SC, NJ, OK, MN, MI, NC, OH, AZ, WI, CA, PA, ID.
Derived failure modes
-
Unknown
Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma.