Recall Z-0021-2020— Galemed Corporation

Name: FDA recall Z-0021-2020
Creator: U.S. Food and Drug Administration
Published: 2019-05-30

Class I · Terminated

Class I FDA medical device recall by Galemed Corporation, initiated 2019-05-30, terminated 2024-05-20. It names one FDA 510(k) clearance: K110383. Product: Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559. Reason: Reports of pressure relief manifold venting gas below the standard pressure..

Recalling firm: Galemed Corporation
Classification: Class I
Status: Terminated
Initiated: 2019-05-30
Terminated: 2024-05-20
Firm location: I-Lan, Taiwan

510(k) clearances named in this recall

1 on FDA's record

K110383 — BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20A Plus Medical·cleared 2011-08-01

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

Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559

Reason for recall

Reports of pressure relief manifold venting gas below the standard pressure.

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