Recall Z-1320-2016— Cardinal Health
Class II · Terminated
Class II FDA medical device recall by Cardinal Health, initiated 2016-02-29, terminated 2018-03-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant.. 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..
- Recalling firm
- Cardinal Health
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-29
- Terminated
- 2018-03-02
- Firm location
- Mc Gaw Park, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.