The Better-Bladder recall
The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
Why was The Better-Bladder 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number: 5290-201001 UDI: (01)00851997007004(10)5290-201001(17)20231021(11)20201021
- Product
- The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
- Recalling firm
- Circulatory Technology Inc.
- Quantity
- 147 units
- Distribution
- US Nationwide distribution in the states of AL, AR, CA, DC, FL, GA, IN, MO, NC, PA, SC, TX.
- Recall date
- June 23, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)