Teleflex Inc has issued a recall for certain lots of the GaleMed Babi.Plus 12.5 cm H2O Pressure Relief Manifold, which is most commonly used for bubble CPAP therapy, according to a company news alert.
Teleflex receives the product from the manufacturer GaleMed Corporation and is one of its distributors for this product within the United States.
The recalled products are designed for use with humans with a body mass of less than 10 Kg requiring a pressure limitation system to eliminate excessive pressure should an obstruction occur between gas supply and exhalation port during continuous gas flow therapy up to 12 liters per minute in hospital and transport environments. The most used application of the pressure relief manifold (PRM) is Bubble CPAP therapy. The products involved in this recall are as follows:
According to the company, the voluntary recall is due to a Medical Device Recall Notice which Teleflex received from GaleMed Corp. 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.
This may be easily identified by either visually inspecting the pressure relief valve to confirm that the valve is properly seated on the valve seat and/or performing a pre-patient connection to the BCPAP system or performing a system pressure test, as an affected valve will not allow the system to pressurize.
GaleMed has received two (2) 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.
These recalled products were distributed from October 2018 to May 2019.
The US FDA classified the original recall of the GaleMed Babi.Plus 12.5 cm H2O Pressure Relief Manifold as a Class I recall. FDA defines a Class I recall as, “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
Consumers who have affected product should immediately discontinue use and return all affected product to Teleflex.
Consumers with questions may contact the company at 1-866-396-2111; 8am to 7pm, ET, Monday through Friday or email [email protected]