FDAClass IIApril 13, 2016

Gomco Style Circumcision Clamp Trays is an instrument recall

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

Why was Gomco Style Circumcision Clamp Trays is an instrument 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
Recalling firm
Cardinal Health
Quantity
SSI-0034: 380 units and 10-1100: 60 units
Distribution
Nationwide Distribution including AR, KS, WV, , NC, TX, AL, MS and VA.
Recall date
April 13, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls