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Circulatory Technology Inc recalls The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tr
Recalled September 21, 2016 · FDA recall Z-2832-2016 · Circulatory Technology
Hazard
The seal between the balloon and the housing may leak. · FDA Class II
Units
20 units
Sold at
US Distribution to states of: LA, MI, NY, OH, OR & TX.
Description
The seal between the balloon and the housing may leak.
Product
The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blood contact when measurements of blood pressure in extracorporeal circuits are made during short and long term procedures. The pressure signal can be used to control pump speed. It is also used as an inline reservoir to provide compliance in the circuit during short and long term procedures. Measures 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 →