Recall Z-1878-2018 ยท ODG Endoscopic Ultrasound System, Gastroenterology-Urology
Micro-Tech (Nanjing) Co., Ltd.
Trident Endoscopic Ultrasonic Aspiration Needle (FNA)
| Date | Mar 12, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| 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). |
| Quantity | 40 total |
| Distribution | US distribution to one distributor in MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172309 | Endoscopic Ultrasound Aspiration Needle Micro-Tech (Nanjing) Co., Ltd., Sep 29, 2017 |