Home / Recalls / Galemed Corporation / Z-0021-2020

Z-0021-2020 Class I Terminated

Recalled by Galemed Corporation — I-Lan

Recall Details

Product Type
Devices
Report Date
January 1, 2020
Initiation Date
May 30, 2019
Termination Date
May 20, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12000

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.

Distribution Pattern

US distribution to distributors in the states of: NC and NV.

Code Information

UDI: 24710810093559 Lot: 180718, 181107, 181127, 190220, and 190220-190610 (Reworked Product)

Other recalls by Galemed Corporation

  • Z-0020-2020 Class I — Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810 (May 30, 2019)
  • Z-0022-2020 Class I — Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen S (May 30, 2019)