Recall Z-0947-2017
Aesculap Implant Systems LLC · initiated October 28, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Material Code MG096R (1.1 CM) MG097R (1.3 CM) MG227 (1.45CM) MG228 (1.6CM) MG229 (2.1 CM) MG230 (2.6CM)
Reason for recall
Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps.
FDA-determined cause: Under Investigation by firm
Action taken
Aesculap sent an Urgent Medical Device Recall Notification letter dated October 28, 2016, to all affected customers were sent an Urgent Medical Device Recall Notification letter via Fed-Ex overnight.. Customers were asked to immediately remove the affect product from their inventory and return to Aesculap. A return label was provided to efficiently remove and return the affected products. Customers with questions should call 610-984-9414. For questions regarding this recall call 800-258-1946.
Details
- Recall number
- Z-0947-2017
- Initiated
- October 28, 2016
- Terminated
- January 30, 2018
- Product code
- HFX – Clamp, Circumcision
- Quantity
- 437 units
- Distribution
- Nationwide Distribution
- Recalling firm
- Aesculap Implant Systems LLC, Center Valley, PA