Recall Z-1138-2022— Baxter Healthcare Corporation

Name: FDA recall Z-1138-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-26

Class I · Terminated

Class I FDA medical device recall by Baxter Healthcare Corporation, initiated 2022-04-26, terminated 2024-08-20. It names one FDA 510(k) clearance: K200988. Product: In-Line ventilator adaptor. Reason: There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment..

Recalling firm: Baxter Healthcare Corporation
Classification: Class I
Status: Terminated
Initiated: 2022-04-26
Terminated: 2024-08-20
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K200988 — Maximus SystemHill-Rom Services Pte, Ltd.·cleared 2020-05-26

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

In-Line ventilator adaptor

Reason for recall

There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.

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