Circulatory Technology Inc recalls The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit…

Recall date

July 1, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0057-2017

FDA classification

Class III

Brand / firm

Circulatory Technology Inc

Sold / distributed

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.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.