BEUDAMED
    FDA Enforcement Class II Ongoing

    Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319

    Recall: Z-2958-2018 · Reported September 5, 2018

    Enforcement

    Recall Number
    Z-2958-2018
    Event ID
    80804
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Covidien LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 5, 2018
    Initiation Date
    July 26, 2018
    Classification Date
    August 30, 2018
    Address
    60 Middletown Ave, N/A, North Haven, CT, 06473-3908, United States

    Description

    Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems. Product Number/CFN: 186-0208 UDI-Device Identifier (GTIN/UPN): 10884521130319

    Reason

    Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems

    Code Info

    Batteries with date code 3114 or older (Week 31 of 2014)

    Distribution

    Nationwide Foreign: Australia, New Zealand

    Quantity

    BIS 46,961; Spare Batteries: 6,937