Device product
Gomco Circumcision Clamps with separate O-Ring Component: The device is packaged non-sterile and has no shelf-life The Gomco clamp is intended to be used for circumcision surgeries
Z-0947-2017
Product summary
- Event
- Event 75937
- Status
- Terminated
- Classification
- Class II
- Quantity
- 437 units
- Official record key
device-enforcement:Z-0947-2017
Official wording
Reason: Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps.
Code information: Material Code MG096R (1.1 CM) MG097R (1.3 CM) MG227 (1.45CM) MG228 (1.6CM) MG229 (2.1 CM) MG230 (2.6CM)
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps.