FDA-Device2016-04-13Class II

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

Cardinal Health
Hazard

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.

Sold states
Nationwide Distribution including AR, KS, WV, , NC, TX, AL, MS and VA.
Affected count
SSI-0034: 380 units and 10-1100: 60 units
Manufactured in
1430 Waukegan Rd, N/A, Mc Gaw Park, IL, United States
Products
Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1320-2016

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