Z-1878-2018 Class II Terminated
FDA device recall Z-1878-2018 was initiated by Micro-Tech (Nanjing) Co., Ltd. on March 12, 2018 and is designated Class II. 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 hu… The recall status is terminated (terminated August 30, 2018). Affected quantity: 40 total.
Recall Details
- Product Type
- Devices
- Report Date
- May 23, 2018
- Initiation Date
- March 12, 2018
- Termination Date
- August 30, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40 total
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.
Distribution Pattern
US distribution to one distributor in MI.
Code Information
Identifier EUS-22-0-N UPN ES34601 M171226172