Teleflex is one of the U.S. distributors of the device, the Babi.Plus 12.5 cm H2O pressure relief manifold, manufactured by GaleMed. The FDA has designated the recall as Class I.
The recall began June 14 and covers certain lots of the devices distributed from October 2018 to May 2019, according to Teleflex. Those lots are 180806, 180910, 181029, 181105, 181204, 190225 and 190327.
The pressure relief manifold is part of a bubble continuous positive airway pressure (BCPAP) system designed to keep newborns’ lungs from collapsing upon exhalation. Galemed said the BCPAP would not hold pressure because the pressure relief manifold’s internal mechanism was lodged in the upper valve chamber, preventing 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, according to a statement by Teleflex.