Medical device recalls Moderate risk

Cardinal Health recalls Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of…

Recall date
February 29, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1320-2016
FDA classification
Class II
Brand / firm
Cardinal Health
Sold / distributed
Nationwide Distribution including AR, KS, WV, , NC, TX, AL, MS and VA.

Why it was recalled

Two lots of Gomco Style Circumcision Clamp Trays, SSI-0034 and 10-1100 contained a 1.3cm circumcision clamp. They both were labelled as containing a 1.1cm clamp.

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

What was recalled

Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant.

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