Recall Z-1878-2018— Micro-Tech (Nanjing) Co., Ltd.
Class II · Terminated
Class II FDA medical device recall by Micro-Tech (Nanjing) Co., Ltd., initiated 2018-03-12, terminated 2018-08-30. It names one FDA 510(k) clearance: K172309. Product: 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..
- Recalling firm
- Micro-Tech (Nanjing) Co., Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-12
- Terminated
- 2018-08-30
- Firm location
- Nanjing, China
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Trident Endoscopic Ultrasonic Aspiration Needle (FNA)
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.