Circulatory Technology Inc recalls **Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir; Models: BBB38 (ind…

Recall date

September 22, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1171-2018

FDA classification

Class II

Brand / firm

Circulatory Technology Inc

Sold / distributed

**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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

**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)