BEUDAMED
    FDA Enforcement Class II Ongoing

    WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W

    Recall: Z-2305-2021 · Reported August 25, 2021

    Enforcement

    Recall Number
    Z-2305-2021
    Event ID
    88234
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Delta Med SpA
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 25, 2021
    Initiation Date
    June 21, 2021
    Classification Date
    August 16, 2021
    Address
    Via Guido Rossa 20, N/A, Viadana, N/A, N/A, Italy

    Description

    WOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF PIV2210W c) REF PIV2475W

    Reason

    Problems related to the sterilization of the medical devices; possible missing sterility of the medical device

    Code Info

    a) REF PIVD2010W, Lot 1100256 b) REF PIV2210W, Lot 1100316 c) REF PIV2475W, Lot 1200084

    Distribution

    US Nationwide distribution in the states of FL and MN.

    Quantity

    40,000 units