FDA Device recall Z-1352-2020
Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344
- FDA Device
- Class II
- terminated
- Published 2020-03-04
On 2020-03-04 the FDA classified a Class II recall of Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344 by Breas Medical, citing the outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1352-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-28 |
| Published | 2020-03-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Breas Medical |
| Distribution | US |
Product
Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the Vivo 50 and Vivo 65 ventilators - Product Usage: The protective cover is intended for additional protection of the Vivo 50, Vivo 55, Vivo 60 and Vivo 65 ventilators during transportation, and in hospital, institutional, and home care environments. It can be used while the Vivo ventilators is operating, for example mounted on a wheelchair, in a personal vehicle, or carried by hand. The device is not to be used with the protective cover while positioned in a warm place, such as in direct sunlight or close to a radiator. The protective cover includes the following features: transparent window for accessing front panel and buttons; port for patient circuit, cables, O2 inlet, and standby button; cooling air inlet; patient air inlet; straps for safe mounting; and cooling air outlet.
Reason
The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover.
Identifiers
| code_info | The cover does not have a lot number; these covers were distributed between 01/11/2018 and 12/17/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1352-2020%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.