**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)
Class I - DangerousWhat Should You Do?
- Check if you have this product: **Recall expanded to add these models: BBB38, Lot Number: 5300-S19813; BBB38NS, Lot Number: 1707-1 and 170903
- 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:
- terminated
Product Information
Full Description:
**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)
Product Codes/Lot Numbers:
**Recall expanded to add these models: BBB38, Lot Number: 5300-S19813; BBB38NS, Lot Number: 1707-1 and 170903
Distribution:
Distributed in: AL, AR, CA, FL, GA, IL, IN, KY, MD, MO, NJ, NY, OH, OR, PA, TN, TX, VA, WA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1171-2018
Related Recalls
The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
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.