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
FDA Recall Z-0237-2019 · Posted None
Advertisement
Recalling FirmMicro-Tech (Nanjing) Co., Ltd.
Recall StatusTerminated
Product CodeGEN
Date Initiated2018-09-20
Date Terminated2019-10-21
Product Quantity1360 pcs
Reason for Recall
Single-Use Biopsy Forceps box contains incorrect product, instead it contains some Grasping Forceps units
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 [email protected]
Customers with questions may contact Angela Smith 1-877-552-4027
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide Distribution in the states of AL, CA, IN, FL, GA, MO, MT, NV, OK, OR, PA TX & Washington D.C.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement