FDA Recall
Terminated
SAROS Oxygen System Model 3000
Recall: Z-0248-2020
·
Initiated September 16, 2019
Recall
- Recall Number
- Z-0248-2020
- Event Number
- 83850
- Firm
- Caire, Inc.
- FEI Number
- 3004972304
- Product Code
- CAW
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- September 16, 2019
- Terminated
- December 16, 2020
- Address
- 2200 Airport Industrial Dr, Ste 500, Ball Ground, GA, 30107-4686
Description
SAROS Oxygen System Model 3000
Reason
There is an electronics control issue that causes the unit to not power on with battery power only.
Action
The firm initiated the recall by email on 09/16/2019. The firm explained the issue and requested the return of the units.
Distribution
US and Chile
Quantity
10 units