FDAClass IINovember 6, 2019

SAROS Oxygen System recall

SAROS Oxygen System Model 3000

Why was SAROS Oxygen System recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
SAROS Oxygen System Model 3000
Recalling firm
Caire, Inc.
Quantity
10 units
Distribution
US and Chile
Recall date
November 6, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls