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Circulatory Technology Inc recalls The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circu
Recalled October 19, 2016 · FDA recall Z-0057-2017 · Circulatory Technology
Hazard
Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm. · FDA Class III
Units
958 units
Sold at
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.
Description
Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.
Product
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.
Manufacturer(s)
Circulatory Technology Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →