PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: April 13, 2016 Initiated: February 29, 2016 #Z-1320-2016

Product Description

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

Reason for Recall

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.

Details

Recalling Firm
Cardinal Health
Units Affected
SSI-0034: 380 units and 10-1100: 60 units
Distribution
Nationwide Distribution including AR, KS, WV, , NC, TX, AL, MS and VA.
Location
Mc Gaw Park, IL

Frequently Asked Questions

What product was recalled?
Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant.. Recalled by Cardinal Health. Units affected: SSI-0034: 380 units and 10-1100: 60 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 13, 2016. Severity: Moderate. Recall number: Z-1320-2016.