Recall Z-1548-2021— Atos Medical AB
Class II · Terminated
Class II FDA medical device recall by Atos Medical AB, initiated 2021-03-29, terminated 2022-02-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.. Reason: Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma..
- Recalling firm
- Atos Medical AB
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-03-29
- Terminated
- 2022-02-17
- Firm location
- Horby, Sweden
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.