Recall Z-0020-2020— Galemed Corporation

Name: FDA recall Z-0020-2020
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 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562. 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 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562

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.