I-Lan, Taiwan
Galemed Corporation recalls
1 recall recorded since 2018, most recently on 30 May 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)1
Terminated Class I Medical devices
- Recall started
- 30 May 2019
- Terminated
- 20 May 2024
- Reason
- Reports of pressure relief manifold venting gas below the standard pressure.
- Distribution
- US distribution to distributors in the states of: NC and NV.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0021-2020, Z-0020-2020, Z-0022-2020
- Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
- Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
- Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.