FDA-Device2016-10-19Class III
The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
Circulatory Technology Inc
Hazard
Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.
Sold states
US Nationwide Distribution to states of: AL, AR, CA, Washington, D.C., FL, GA, IA, IL, IN, KY, LA, MI, MS, NC, NJ, NY, OH, OK, PA, SC, TN, TX & VA.
Affected count
958 units
Manufactured in
21 Singworth St, N/A, Oyster Bay, NY, United States
Products
The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0057-2017Don't want to check this manually?
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