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Teleflex Recalls GaleMed Babi.Plus 12.5 Cm H2O Pressure Relief Manifold

Teleflex Inc. (TFX) announced Monday the worldwide voluntary recall on June 14, 2019 of certain lots of the GaleMed Corp. (third party manufacturer) Babi.Plus 12.5 cm H2O Pressure Relief Manifold.

Teleflex said it receives the product from the manufacturer GaleMed and is one of its distributors for this product within the United States. GaleMed is the legal manufacturer of these products.

This voluntary recall is due to a Medical Device Recall Notice which Teleflex received from the GaleMed Corp. These recalled products were distributed from October 2018 to May 2019.

GaleMed advises that the Babi.Plus 12.5cm H2O Pressure Relief Manifold is being recalled because it has been reported that the bubble continuous positive airway pressure (BCPAP) system would not hold pressure as the pressure relief manifold (PRM) internal mechanism was lodged in the upper valve chamber which prevented engagement with the valve seat.

GaleMed has received two reports of device malfunction in which the device vented gas below the stated pressure. Though no injuries have been reported, use of an affected device with the valve not properly seated on the valve seat could result in lower blood oxygen levels and rebreathing of exhaled carbon dioxide.

The U.S. Food and Drug Administration (FDA) classified the original recall of the GaleMed Babi.Plus 12.5 cm H2O Pressure Relief Manifold as a Class I recall. Consumers who have affected product should immediately discontinue use and return all affected product to Teleflex.

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