Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)

Reason: 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.

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

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.