FDAFDA · Food and drugs·Recall number Z-1320-2016
Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
Published April 13, 2016 · Recall initiated: February 29, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cardinal Health
- Distributor
- Nationwide Distribution including AR, KS, WV, , NC, TX, AL, MS and VA.
- Lot
- SSI-0034 with LOT# 462799 & 476803 10-1100 with LOT# 462788 & 485406
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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