Recall Z-0336-2023— Caire, Inc.

Name: FDA recall Z-0336-2023
Creator: U.S. Food and Drug Administration
Published: 2022-10-10

Class I · Terminated

Class I FDA medical device recall by Caire, Inc., initiated 2022-10-10, terminated 2024-08-19. It names one FDA 510(k) clearance: K800742. Product: CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit. Reason: An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units..

Recalling firm: Caire, Inc.
Classification: Class I
Status: Terminated
Initiated: 2022-10-10
Terminated: 2024-08-19
Firm location: Ball Ground, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K800742 — LIBERATOR/STROLLER II SYSTEMCryogenic Assoc.·cleared 1980-05-23

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

CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit

Reason for recall

An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.

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