Home / Recalls / Galemed Corporation / Z-0022-2020

Z-0022-2020 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
14964

Product Description

Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802

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: 04710810100802 Lot: 180806, 180910, 181029, 181105, 181204, 190225, 190327

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-0021-2020 Class I — Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, (May 30, 2019)