Z-1862-2021 Class II Ongoing
FDA device recall Z-1862-2021 was initiated by Circulatory Technology Inc. on April 27, 2021 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 147 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 23, 2021
- Initiation Date
- April 27, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 147 units
Product Description
The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
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 Pattern
US Nationwide distribution in the states of AL, AR, CA, DC, FL, GA, IN, MO, NC, PA, SC, TX.
Code Information
Lot Number: 5290-201001 UDI: (01)00851997007004(10)5290-201001(17)20231021(11)20201021