Z-1320-2016 Class II Terminated
FDA device recall Z-1320-2016 was initiated by Cardinal Health on Feb 29, 2016 and is designated Class II. 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. The recall status is terminated (terminated Mar 2, 2018). Affected quantity: SSI-0034: 380 units and 10-1100: 60 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 13, 2016
- Initiation Date
- Feb 29, 2016
- Termination Date
- Mar 2, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- SSI-0034: 380 units and 10-1100: 60 units
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.
Distribution Pattern
Nationwide Distribution including AR, KS, WV, , NC, TX, AL, MS and VA.
Code Information
SSI-0034 with LOT# 462799 & 476803 10-1100 with LOT# 462788 & 485406
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1320-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026