Medical device recalls Moderate risk

Circulatory Technology Inc recalls Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38

Recall date
March 3, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2050-2016
FDA classification
Class II
Brand / firm
Circulatory Technology Inc
Sold / distributed
US Distribution to the states of: CA, IN, MI, NY, PA, TX & VA

Why it was recalled

The seal between the balloon and the housing may leak.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38

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