BEUDAMED
    FDA Enforcement Class II Terminated

    Rotating IV Pole Rotating IV Pole falls under the category classified as capital equipment, an optional accessory that may be purchased to facilitate attachment and consolidation of patient equipment to one central patient care area. Devices commonly attached to IV poles include IV pumps, feeding pumps, and infusion fluid bags. Products used on: Giraffe OmniBed, Giraffe Warmers, Panda Warmers and Giraffe Incubators and Giraffe Shuttle. The IV pole also can be mounted to the Care Plus Incubator and Panda IWS.

    Recall: Z-1181-2018 · Reported April 4, 2018

    Enforcement

    Recall Number
    Z-1181-2018
    Event ID
    79452
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ohmeda Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 4, 2018
    Initiation Date
    December 1, 2017
    Classification Date
    March 26, 2018
    Termination Date
    September 17, 2019
    Address
    8880 Gorman Rd, Laurel, MD, 20723-5800, United States

    Description

    Rotating IV Pole Rotating IV Pole falls under the category classified as capital equipment, an optional accessory that may be purchased to facilitate attachment and consolidation of patient equipment to one central patient care area. Devices commonly attached to IV poles include IV pumps, feeding pumps, and infusion fluid bags. Products used on: Giraffe OmniBed, Giraffe Warmers, Panda Warmers and Giraffe Incubators and Giraffe Shuttle. The IV pole also can be mounted to the Care Plus Incubator and Panda IWS.

    Reason

    There is the potential for the Rotating IV Pole to fall. A fall could result in an injury to a bystander holding the patient or to the operator.

    Code Info

    Model Number(s): 6600-0851-800 Affected lot codes are within LAU13921134 - LAU14720444

    Distribution

    USA (nationwide)

    Quantity

    1,179 (1,004 US; 175 OUS)