Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Trident Endoscopic Ultrasonic Biopsy Needle (FNB)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Trident Endoscopic Ultrasonic Biopsy Needle (FNB) see related information
Date Initiated by Firm March 12, 2018
Create Date May 15, 2018
Recall Status1 Terminated 3 on August 30, 2018
Recall Number Z-1877-2018
Recall Event ID 79911
510(K)Number K172309  
Product Classification Endoscopic ultrasound system, gastroenterology-urology - Product Code ODG
Product Trident Endoscopic Ultrasonic Biopsy Needle (FNB)
Code Information Identifier EUS-22-1-N UPN ES34591 M171226171
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 2		 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 and Original Applicant = Micro-Tech (Nanjing) CO.,Ltd.
-
-