BEUDAMED
    FDA Enforcement Class II Completed

    Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, Angled 6 units, Individual Packaging Label: ProTekt Sharps Safety Knives - REF: PG 44620MU,2.2mm double Bevel Slit, Sterile R, Angled 1 unit, Handle Labeling; 2.5mm slit double bevel

    Recall: Z-1120-2022 · Reported June 1, 2022

    Enforcement

    Recall Number
    Z-1120-2022
    Event ID
    89827
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    International Science & Technology, LP, DBA Diamatrix Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 1, 2022
    Initiation Date
    February 24, 2022
    Classification Date
    May 20, 2022
    Address
    210 Nursery Rd, Spring, TX, 77380-1943, United States

    Description

    Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, Angled 6 units, Individual Packaging Label: ProTekt Sharps Safety Knives - REF: PG 44620MU,2.2mm double Bevel Slit, Sterile R, Angled 1 unit, Handle Labeling; 2.5mm slit double bevel

    Reason

    Surgical knives may contain incorrect description printed on handles. Specifically, some surgical knife handles may contain a size of "2.5mm" when the actual size is "2.2mm".

    Code Info

    Item # PG 44620MU; Lot # : B923LUC

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of MN, TX and the country of Germany.

    Quantity

    90 units