Z-0817-2018 Class II Terminated
FDA device recall Z-0817-2018 was initiated by Circulatory Technology Inc on September 22, 2017 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 terminated (terminated May 20, 2020). Affected quantity: 840.
Recall Details
- Product Type
- Devices
- Report Date
- March 7, 2018
- Initiation Date
- September 22, 2017
- Termination Date
- May 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 840
Product Description
Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)
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
**Requested update** Distributed in 19 states: AL, AR, CA, FL, GA, IL, IN, KY, MD, MO, NJ, NY, OH, OR, PA, TN, TX, VA, WA, and the District of Columbia.
Code Information
**Recall expanded to add additional lot numbers highlighted with "**": BB14 Lot Numbers: 5290-S19785, 5290-S19786, 5290-S19872, **5290-S19925; BB14NS Lot Numbers: 17062201, 17062202, 17062203, and **170905