Reported Jun 23, 2021 · Ongoing
The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
Circulatory Technology Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Circulatory Technology Inc. · 21 Singworth St · Oyster Bay, NY · 11771-3703
Is this the product you have?
- The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits
- ModelBB14
- Lot codes and dates
- Lot Number5290-201001
- UDI(01)00851997007004(10)5290-201001(17)20231021(11)20201021
- Amount recalled
- 147 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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