BEUDAMED
    FDA Enforcement Class II Terminated

    Mueller Knife Handle, Hexagonal - Product Usage: Intended to hold surgical blades.

    Recall: Z-2400-2020 · Reported June 24, 2020

    Enforcement

    Recall Number
    Z-2400-2020
    Event ID
    85747
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Carefusion 2200 Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 24, 2020
    Initiation Date
    May 18, 2020
    Classification Date
    June 18, 2020
    Termination Date
    April 25, 2021
    Address
    75 N Fairway Dr, Vernon Hills, IL, 60061-1845, United States

    Description

    Mueller Knife Handle, Hexagonal - Product Usage: Intended to hold surgical blades.

    Reason

    Becton Dickinson and Company, is conducting a voluntary recall on the V. MuellerTM 3H Knife Handles catalog number listed in the table above. BD has been informed by our supplier that the external threads on some of the collets (Figure 1) contain a machining burr, potentially causing the collet to not fully seat in the knife handle (Figure 2), inhibiting complete grip of the inserted knife blade possibly resulting in a loose blade.

    Code Info

    Model Numbers: OP0702 and OP0703. Model OP0702, Lot C20VAA ( 4 inch length) Model OP0703, Lot D17VAA (6 inch length)

    Distribution

    US Nationwide distribution including in the states of CA, FL, VA and KY.

    Quantity

    358 units