BEUDAMED
    FDA Enforcement Class II Terminated

    PowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kit; Catalog Numbers CPA00001 (UDI 00801741098345), CPA00002 (UDI 00801741098352), CPA00028 (UDI 00801741129728), CPA00032 (UDI 00801741137501), CPA00033 (UDI 00801741137501), CPA00036 (UDI 00801741138911), CPA00051 (UDI 00801741175718), CPA00055 UDI 00801741182181), CPA00056 (UDI 00801741182907)

    Recall: Z-2661-2020 · Reported July 29, 2020

    Enforcement

    Recall Number
    Z-2661-2020
    Event ID
    85853
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 29, 2020
    Initiation Date
    June 19, 2020
    Classification Date
    July 18, 2020
    Termination Date
    July 29, 2022
    Address
    1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States

    Description

    PowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kit; Catalog Numbers CPA00001 (UDI 00801741098345), CPA00002 (UDI 00801741098352), CPA00028 (UDI 00801741129728), CPA00032 (UDI 00801741137501), CPA00033 (UDI 00801741137501), CPA00036 (UDI 00801741138911), CPA00051 (UDI 00801741175718), CPA00055 UDI 00801741182181), CPA00056 (UDI 00801741182907)

    Reason

    Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.

    Code Info

    Catalog Numbers CPA00001 (UDI 00801741098345), CPA00002 (UDI 00801741098352), CPA00028 (UDI 00801741129728), CPA00032 (UDI 00801741137501), CPA00033 (UDI 00801741137501), CPA00036 (UDI 00801741138911), CPA00051 (UDI 00801741175718), CPA00055 UDI 00801741182181), CPA00056 (UDI 00801741182907). Lot Numbers: REEN0212 REEP2685 REEP3660 REEQ3563 REER1968 REDZ0705 REEP3313 REEP3547 REER0577 REEN0214 REEQ3569 REDY3552 REEN1934 REEP3280 REEP3552 REER1115 REEN0218 REEP3659 REEP1436 REER0298 REER1335 REDY0992 REEN0278 REEP1437 REEQ0232

    Distribution

    Worldwide Distribution

    Quantity

    5,296,132 total