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Recall Observatory FDA recall evidence

Device product

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

Z-1320-2016

February 29, 2016

Class II

Product summary

Firm
Cardinal Health
Event
Event 73497
Status
Terminated
Classification
Class II
Quantity
SSI-0034: 380 units and 10-1100: 60 units
Official record key
device-enforcement:Z-1320-2016

Official wording

Reason: 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.

Code information: SSI-0034 with LOT# 462799 & 476803 10-1100 with LOT# 462788 & 485406

Distribution pattern: Nationwide Distribution including AR, KS, WV, , NC, TX, AL, MS and VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.