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

Is my product affected?

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

• UPC 00851997007004

Check against the official notice below — it lists the full affected range.

What happened

Circulatory Technology Inc. is recalling the Better-Bladder (BB) Model BB14, a component used in extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. The device may collapse during use, which can increase resistance to blood flow in the venous line and reduce overall circuit blood flow. A total of 147 units from Lot Number 5290-201001 have been distributed nationwide across Alabama, Arkansas, California, Washington D.C., Florida, Georgia, Indiana, Missouri, North Carolina, Pennsylvania, South Carolina, and Texas.

The recall notice does not specify a remedy or corrective action that affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution in the states of AL, AR, CA, DC, FL, GA, IN, MO, NC, PA, SC, TX. Quantity: 147 units Lot/code info: Lot Number: 5290-201001 UDI: (01)00851997007004(10)5290-201001(17)20231021(11)20201021

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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