medical Class II Updated 2021-06-23

Circulatory Technology Inc. recalls The Better-Bladder (BB), part of extracorporeal membrane oxy

Recalled Product

The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14


Hazard / Issue

The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line and cause a drop in circuit blood flow.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number: 5290-201001 UDI: (01)00851997007004(10)5290-201001(17)20231021(11)20201021
View official government recall

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