Date Initiated by Firm |
October 28, 2016 |
Create Date |
January 05, 2017 |
Recall Status1 |
Terminated 3 on January 30, 2018 |
Recall Number |
Z-0947-2017 |
Recall Event ID |
75937 |
Product Classification |
Clamp, circumcision - Product Code HFX
|
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 |
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) |
Recalling Firm/ Manufacturer |
Aesculap Implant Systems LLC 3773 Corporate Pkwy Center Valley PA 18034-8217
|
For Additional Information Contact |
800-258-1946
|
Manufacturer Reason for Recall |
Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
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. |
Quantity in Commerce |
437 units |
Distribution |
Nationwide Distribution |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|