The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Number: 5290-201001 UDI: (01)00851997007004(10)5290-201001(17)20231021(11)20201021
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Circulatory Technology Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
Product Codes/Lot Numbers:
Lot Number: 5290-201001 UDI: (01)00851997007004(10)5290-201001(17)20231021(11)20201021
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1862-2021
Related Recalls
**Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir; Models: BBB38 (individual, sterile, pouched) and BBB38NS (sold bulk to kit manufacturers)
Circulatory Technology
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.
Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)
Circulatory Technology
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.
The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
Circulatory Technology
Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.