FDA-Device2018-03-07Class II
Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)
Circulatory Technology Inc
Hazard
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.
Sold states
**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.
Affected count
840
Manufactured in
21 Singworth St, N/A, Oyster Bay, NY, United States
Products
Better-Bladder cardiopulmonary bypass blood reservoir; Models: BB14 (individual, sterile, pouched) and BB14NS (sold bulk to kit manufacturers)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0817-2018Don't want to check this manually?
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