Galemed Corporation: Medical Device Recall in 2020 - (Recall #: Z-0022-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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

Product Classification:

Class I

Date Initiated: May 30, 2019

Date Posted: January 1, 2020

Recall Number: Z-0022-2020

Event ID: 83318

Reason for Recall:

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

Status: Terminated

Product Quantity: 14964

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated