Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0237-2019Class II

Single-Use Biopsy Forceps, JUMBO ALLIGATOR,3.2mm, REF Catalog No. NBF13-01130230, UPN BF40180 (Pouch level)...

Micro-Tech (Nanjing) Co., Ltd. / initiated 2018-09-20 / Terminated

Micro-Tech (Nanjing) Co., Ltd. began a recall of Single-Use Biopsy Forceps, JUMBO ALLIGATOR,3.2mm, REF Catalog No. NBF13-01130230, UPN BF40180 (Pouch level) - BF40181(Case box level) BF40182 (Carton box... on . FDA classified it as Class II and gives the reason as "Single-Use Biopsy Forceps box contains incorrect product, instead it contains some Grasping Forceps units". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0237-2019
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Micro-Tech (Nanjing) Co., Ltd.
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
Product code
GEN Forceps, General & Plastic Surgery
Reason for recall
Single-Use Biopsy Forceps box contains incorrect product, instead it contains some Grasping Forceps units
FDA root 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 [email protected] 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.
Product codes and lots
Lot Number - M180409031 Date of Manufacture - 20180409 Use By - 20220408

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0237-2019
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0237-2019Class IITerminatedVoluntary: Firm initiated