BEUDAMED
    FDA Enforcement Class II Terminated

    Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Breathing Systems - Product Usage: intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.

    Recall: Z-0753-2021 · Reported January 6, 2021

    Enforcement

    Recall Number
    Z-0753-2021
    Event ID
    86800
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Intersurgical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 6, 2021
    Initiation Date
    November 11, 2020
    Classification Date
    December 30, 2020
    Termination Date
    August 9, 2022
    Address
    6757 Kinne St, N/A, East Syracuse, NY, 13057-1215, United States

    Description

    Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Breathing Systems - Product Usage: intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.

    Reason

    The device was assembled with the incorrect exhalation port which can cause gas leakage.

    Code Info

    Model Number: B0062001 Lot Numbers: 4200283 and 4200286 UDI Codes: (01)00081647202239(10)4200286 (01)00081647202239(10)4200283

    Distribution

    All of the devices were shipped to the same distributor (McKesson).

    Quantity

    200 devices