Galemed Corporation: Medical Device Recall in 2020 - (Recall #: Z-0020-2020)

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, REF 1030, RX Only, UDI: 04710810093562

Product Classification:

Class I

Date Initiated: May 30, 2019

Date Posted: January 1, 2020

Recall Number: Z-0020-2020

Event ID: 83318

Reason for Recall:

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

Status: Terminated

Product Quantity: 2880

Code Information:

UDI: 04710810093562 Lot: 180718, 181204, 190215, and 190610 (Reworked Product)

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated