FDA Device recall Z-1548-2021
Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a trac…
- FDA Device
- Class II
- terminated
- Published 2021-05-19
On 2021-05-19 the FDA classified a Class II recall of Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a trac… by Atos Medical Ab, citing provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1548-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-29 |
| Published | 2021-05-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Atos Medical Ab |
| Distribution | US |
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.
Identifiers
| code_info | Lot Numbers: 2012158 and 2012124 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1548-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.