Circulatory Technology Inc: Medical Device Recall in 2018 - (Recall #: Z-0817-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 22, 2017

Date Posted: March 7, 2018

Recall Number: Z-0817-2018

Event ID: 79196

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.

Status: Terminated

Product Quantity: 840

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.

Voluntary or Mandated:

Voluntary: Firm initiated