FDA recall Z-0817-2018

Product

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

**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.

Key facts

Status

Terminated

Initiation date

2017-09-22

Report date

2018-03-07

Termination date

2020-05-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Oyster Bay, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0817-2018