Recall Z-0248-2020

Caire, Inc. · initiated September 16, 2019

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

SAROS Oxygen System Model 3000

Codes / lots: Serial Numbers: CBB0817510005, CBB0817510003, CBB0817510004, CBB0817480515, CBB0817460330, CBB0818281053, CBB0817510001, CBB0817510002, CBB0818330784, CBB0818281052

Reason for recall

There is an electronics control issue that causes the unit to not power on with battery power only.

FDA-determined cause: Nonconforming Material/Component

Action taken

The firm initiated the recall by email on 09/16/2019. The firm explained the issue and requested the return of the units.

Details

Recall number
Z-0248-2020
Initiated
September 16, 2019
Terminated
December 16, 2020
Product code
CAW – Generator, Oxygen, Portable
Quantity
10 units
Distribution
US and Chile
Recalling firm
Caire, Inc., Ball Ground, GA

Official FDA recall record