Class 2 Device Recall Trident Endoscopic Ultrasonic Aspiration Needle (FNA)

• Date Initiated by Firm: March 12, 2018
• Create Date: May 15, 2018
• Recall Status: Terminated on August 30, 2018
• Recall Number: Z-1878-2018
• Recall Event ID: 79911
• 510(K)Number: K172309
• Product Classification: Endoscopic ultrasound system, gastroenterology-urology - Product Code ODG
• Product: Trident Endoscopic Ultrasonic Aspiration Needle (FNA)
• Code Information: Identifier EUS-22-0-N UPN ES34601 M171226172
• Recalling Firm/ Manufacturer: Micro-Tech (Nanjing) Co., Ltd.; High Tech; NO. 10 Gaoke Third Road Nanjing National; Nanjing China
• Manufacturer 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: 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 in Commerce: 40 total
• Distribution: US distribution to one distributor in MI.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = ODG