Reported Mar 4, 2020 · Terminated
Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protective cover) for the…
Breas Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Breas Medical, Inc. · 16 Esquire Rd · North Billerica, MA · 01862-2527
Is this the product you have?
- 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 UsageThe 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 featurestransparent 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
- Lot codes and dates
- The cover does not have a lot number; these covers were distributed between 01/11/2018 and 12/17/2019
- Amount recalled
- 629
Where it was sold
Why it was recalled
The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover.
This product could cause temporary or reversible health problems — stop using it.
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