FDAJuly 1, 2016device

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.

What to do

FDA enforcement status: Terminated

Brands named

circulatory technologycirculatory

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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