The U.S. Food and Drug Administration (FDA) has issued a Class I recall of Teleflex’s Galemed Babi.Plus 12.5 cm H2O Pressure Relief Manifold. A Class I recall is the most serious type of recall as use of these devices may cause serious injuries or death.
The Babi.Plus Pressure Relief Manifold is used as part of a breathing circuit designed to assist the breathing of infant patients who weigh no more than 10 kilograms. The affected devices are sold in multiples sizes, identified above under recalled product. They are used in healthcare facilities, such as neonatal critical care units, delivery rooms, and pediatric critical care units.
Teleflex is recalling the Babi.Plus Pressure Relief Manifold system because the Pressure Relief Manifold (PRM) in the Babi.Plus 12.5 cm H2O Pressure Relief Manifold does not hold pressure when initially set up on a patient. This issue is due to a dislodged valve not being properly seated, resulting in loss of pressure in the system. Use of the affected devices may cause serious adverse health consequences, including lower blood oxygen levels, slow heart rate, stopped breathing (apnea), rebreathing of exhaled carbon dioxide by the patient and need for medical intervention and resuscitation.
Galemed has separately recalled the Babi.Plus Pressure Relief Manifold system due to two complaints it received associated with device malfunction. Teleflex, a distributor for Galemed, has not received any complaints for this issue. No injuries or deaths were reported.
