BEUDAMED
    FDA Enforcement Class I Terminated

    Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.

    Recall: Z-0009-2020 · Reported November 13, 2019

    Enforcement

    Recall Number
    Z-0009-2020
    Event ID
    83119
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    TELEFLEX-MORRISVILLE
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 13, 2019
    Initiation Date
    June 14, 2019
    Classification Date
    November 6, 2019
    Termination Date
    June 12, 2024
    Address
    3015 Carrington Mill Blvd, N/A, Morrisville, NC, 27560-5437, United States

    Description

    Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.

    Reason

    Device vented gas below the stated pressure.

    Code Info

    Catalog # 2691 SKU #: XTF0046 Lot #'s: 180806, 180910, 181029, 181105, 181204, 190225 and 190327

    Distribution

    US nationwide distribution. AL, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TX, VA, WA and WY

    Quantity

    9,312 each