FDA recall Z-0237-2019

Micro-Tech (Nanjing) Co., Ltd. · Class II · device

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

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2018-09-20
Report date
2018-10-31
Termination date
2019-10-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Nanjing, N/A, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0237-2019