FDA-Device2021-06-23Class II
The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
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
US Nationwide distribution in the states of AL, AR, CA, DC, FL, GA, IN, MO, NC, PA, SC, TX.
Affected count
147 units
Manufactured in
21 Singworth St, Oyster Bay, NY, United States
Products
The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits. Model: BB14
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1862-2021Don't want to check this manually?
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