FDA Recall Terminated

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

Recall: Z-0237-2019 · Initiated September 20, 2018

Recall

Recall Number
Z-0237-2019
Event Number
81176
Firm
Micro-Tech (Nanjing) Co., Ltd. High Tech NO. 10 Gaoke Third Road Nanjing National Nanjing China
FEI Number
3004837686
Product Code
GEN
Status
Terminated
Root Cause
Under Investigation by firm
Initiated
September 20, 2018
Terminated
October 21, 2019

Description

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

Reason

Single-Use Biopsy Forceps box contains incorrect product, instead it contains some Grasping Forceps units

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 [email protected] Customers with questions may contact Angela Smith 1-877-552-4027

Distribution

US Nationwide Distribution in the states of AL, CA, IN, FL, GA, MO, MT, NV, OK, OR, PA TX & Washington D.C.

Quantity

1360 pcs