FDA Recall
Terminated
Trident Endoscopic Ultrasonic Aspiration Needle (FNA)
Recall: Z-1878-2018
·
Initiated March 12, 2018
Recall
- Recall Number
- Z-1878-2018
- Event Number
- 79911
- Firm
- Micro-Tech (Nanjing) Co., Ltd. High Tech NO. 10 Gaoke Third Road Nanjing National Nanjing China
- FEI Number
- 3004837686
- Product Code
- ODG
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- March 12, 2018
- Terminated
- August 30, 2018
Description
Trident Endoscopic Ultrasonic Aspiration Needle (FNA)
Reason
The combination of the firmness of the mass, the potential endoscope and elevator position combined with the force required to penetrate the mass may contribute to the breakage of the needle in the human body, which could cause injury.
Action
The firm emailed the distributor on March 12, 2018. (initial consignee). The consignee has been requested to return all products to the Manufacturer (Micro-Tech Nanjing).
Distribution
US distribution to one distributor in MI.
Quantity
40 total