BEUDAMED
    FDA Enforcement Class II Ongoing

    REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,

    Recall: Z-1273-2022 · Reported June 29, 2022

    Enforcement

    Recall Number
    Z-1273-2022
    Event ID
    90201
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Bard Peripheral Vascular Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 29, 2022
    Initiation Date
    April 22, 2022
    Classification Date
    June 21, 2022
    Address
    1625 W 3rd St Bldg 1, Tempe, AZ, 85281-2438, United States

    Description

    REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,

    Reason

    There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the following drainage methods: Universal extension set and drainage bag, vacuum bottle, and wall suction.

    Code Info

    Lot # 0001405396; UDI/DI: (01)10885403076114

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of MS, NC, FL, KS, GA, OH, AZ, NV, OH, IL, MI, MO,IA, CA, PA, AL,WA, TN, IN, NY and the countries of AU, BE, NZ.

    Quantity

    1460 units