Dive Brief:

• Teleflex on Monday said it is recalling certain lots of a respiratory device for infants it distributed in the U.S. for Taiwan-based manufacturer GaleMed.
• Wayne, Pennsylvania-based Teleflex said the device, the Babi.Plus 12.5 cm H2O Pressure Relief Manifold, is being recalled due to reports that the bubble continuous positive airway pressure (BCPAP) system would not hold pressure.
• GaleMed has received two reports of malfunctions in which the device vented gas below a certain pressure level, Teleflex said in a statement. It said there have been no reports of injuries resulting from the problem.

Dive Insight:

Teleflex has been dealing with a massive recall of some of its own products whose malfunctions have been linked to four patient deaths and 18 injuries. The company is recalling millions of Hudson RCI Sheridan and Sheridan model endotracheal tubes due to a risk that the devices could become disconnected from the breathing circuit, leading to insufficient oxygenation and death.

In the new recall involving infant breathing devices, Teleflex said it took the action after receiving a notice from GaleMed. The recalled GaleMed device is part of a system intended to eliminate excessive pressure if an obstruction occurs between the gas supply and exhalation port during continuous gas flow therapy. 

The device is most often used in BCPAP therapy. GaleMed reported that the device’s pressure relief manifold internal mechanism could become lodged in the upper valve chamber, preventing engagement with the valve seat and stopping the system from pressurizing.

The devices are designed for use in infants weighing less than approximately 22 pounds, or 10 kilograms. The faulty pressure mechanism could lower a patient’s blood oxygen level and cause rebreathing of exhaled carbon monoxide, Teleflex said.

The recall, which FDA identified as Class I due to risk of death or serious injury, was announced on June 14 and covers lots 180806, 180910, 181029, 181105, 181204, 190225 and 190327. The products were distributed from October 2018 to May 2019.

Customers who have the devices should immediately discontinue their use and return the products to Teleflex, the company said.