BEUDAMED
    FDA Enforcement Class II Ongoing

    BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001. For collecting, transporting, separating, and processing blood for blood alcohol determination.

    Recall: Z-0095-2023 · Reported October 26, 2022

    Enforcement

    Recall Number
    Z-0095-2023
    Event ID
    90824
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 26, 2022
    Initiation Date
    September 15, 2022
    Classification Date
    October 14, 2022
    Address
    1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001. For collecting, transporting, separating, and processing blood for blood alcohol determination.

    Reason

    The affected product contains isobutylene which has recently demonstrated potential interference in determination of methanol by gas chromatography methods. The interference may lead to false positive results in methanol testing.

    Code Info

    UDI-DI: Case: 50382903670012; Shelf: 30382903670018; Each: 00382903670017; ALL LOTS are affected.

    Distribution

    Distribution US nationwide, Canada, New Zealand, and Hong Kong.

    Quantity

    2,196,000