Recall Z-1878-2018
Micro-Tech (Nanjing) Co., Ltd. · initiated March 12, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Trident Endoscopic Ultrasonic Aspiration Needle (FNA)
Codes / lots: Identifier EUS-22-0-N UPN ES34601 M171226172
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.
FDA-determined cause: Device Design
Action taken
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).
Details
- Recall number
- Z-1878-2018
- Initiated
- March 12, 2018
- Terminated
- August 30, 2018
- Product code
- ODG – Endoscopic Ultrasound System, Gastroenterology-Urology
- Quantity
- 40 total
- Distribution
- US distribution to one distributor in MI.
- Recalling firm
- Micro-Tech (Nanjing) Co., Ltd., Nanjing National Nanjing
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1877-2018 Class II | Trident Endoscopic Ultrasonic Biopsy Needle (FNB)The combination of the firmness of the mass, the potential endoscope and elevator position combined with the… | 03/12/2018Terminated |