Recall Z-0947-2017— Aesculap Implant Systems LLC
Class II · Terminated
Class II FDA medical device recall by Aesculap Implant Systems LLC, initiated 2016-10-28, terminated 2018-01-30. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps..
- Recalling firm
- Aesculap Implant Systems LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-10-28
- Terminated
- 2018-01-30
- Firm location
- Center Valley, PA, United States
Product description
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
Reason for recall
Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps.
Data sourced from openFDA. This site is unofficial and independent of the FDA.