Recall Z-0248-2020— Caire, Inc.

Name: FDA recall Z-0248-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-16

Class II · Terminated

Class II FDA medical device recall by Caire, Inc., initiated 2019-09-16, terminated 2020-12-16. It names one FDA 510(k) clearance: K083163. Product: SAROS Oxygen System Model 3000. Reason: There is an electronics control issue that causes the unit to not power on with battery power only..

Recalling firm: Caire, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-09-16
Terminated: 2020-12-16
Firm location: Ball Ground, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K083163 — OMNI 2 OXYGEN SYSTEMSequal Technologies, Inc.·cleared 2009-10-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.