BEUDAMED
    FDA Enforcement Class II 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 · Reported October 31, 2018

    Enforcement

    Recall Number
    Z-0237-2019
    Event ID
    81176
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Micro-Tech (Nanjing) Co., Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 31, 2018
    Initiation Date
    September 20, 2018
    Classification Date
    October 23, 2018
    Termination Date
    October 21, 2019
    Address
    High Tech, NO. 10 Gaoke Third Road Nanjing National, Nanjing, N/A, N/A, China

    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

    Code Info

    Lot Number - M180409031 Date of Manufacture - 20180409 Use By - 20220408

    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