Z-0248-2020 Class II Terminated
FDA device recall Z-0248-2020 was initiated by Caire, Inc. on September 16, 2019 and is designated Class II. Reason for recall: There is an electronics control issue that causes the unit to not power on with battery power only. The recall status is terminated (terminated December 16, 2020). Affected quantity: 10 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2019
- Initiation Date
- September 16, 2019
- Termination Date
- December 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units
Product Description
SAROS Oxygen System Model 3000
Reason for Recall
There is an electronics control issue that causes the unit to not power on with battery power only.
Distribution Pattern
US and Chile
Code Information
Serial Numbers: CBB0817510005, CBB0817510003, CBB0817510004, CBB0817480515, CBB0817460330, CBB0818281053, CBB0817510001, CBB0817510002, CBB0818330784, CBB0818281052