Class 2 Device Recall Biopsy Forcept (Alligator with Spike)

• Date Initiated by Firm: September 20, 2018
• Create Date: October 24, 2018
• Recall Status: Terminated on October 21, 2019
• Recall Number: Z-0237-2019
• Recall Event ID: 81176
• Product Classification: Forceps, general & plastic surgery - Product Code GEN
• Product: Single-Use Biopsy Forceps, JUMBO ALLIGATOR,3.2mm, REF Catalog No. NBF13-01130230, UPN BF40180 (Pouch level) - BF40181(Case box level) BF40182 (Carton box level) - BF40183(Over shipper level), STERILE
• Code Information: Lot Number - M180409031 Date of Manufacture - 20180409 Use By - 20220408
• Recalling Firm/ Manufacturer: Micro-Tech (Nanjing) Co., Ltd.; High Tech; NO. 10 Gaoke Third Road Nanjing National; Nanjing China
• For Additional Information Contact: Angela Smith; 877-552-4027
• Manufacturer Reason for Recall: Single-Use Biopsy Forceps box contains incorrect product, instead it contains some Grasping Forceps units
• FDA Determined Cause: Under Investigation by firm
• Action: On September 20, 2018 Micro-Tech (Nanjing) Co., Ltd emailed their US distributor advising them of a recall. On September 20,2018, Micro-Tech Endoscopy issued URGENT MEDICAL DEVICE RECALL notices to all U.S. customers. On October 15, 2018, Micro-Tech Endoscopy issued AMENDED URGENT MEDICAL DEVICE RECALL notices to all U.S. customers. The following are Actions To Be Taken By Customers: - Inspect stock and quarantine products subject to recall - Customers with products quarantined & subject to recall should Return the completed Recall Return Response Acknowledgement and Receipt Form via Fed Ex account provided - Do not return USED devices - Customers who DO NOT have devices subject to call are advised to return the completed Recall Return Response Acknowledgement and Receipt Form via email to Quality@mtendoscopy.com Customers with questions may contact Angela Smith 1-877-552-4027
• Quantity in Commerce: 1360 pcs
• Distribution: US Nationwide Distribution in the states of AL, CA, IN, FL, GA, MO, MT, NV, OK, OR, PA TX & Washington D.C.
• 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.