BEUDAMED
    FDA Enforcement Class II Terminated

    Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, Size: 2.37/1.75"W x 9.5"L (60/44 mm x 241 mm), Lot #D424, Expiry date 04/2016, Pre-gelled inside with Aquasonic 100 Ultrasound Transmission Gel Product Usage: For use as a protective cover for medical ultrasound probes/transducers.

    Recall: Z-0145-2015 · Reported November 5, 2014

    Enforcement

    Recall Number
    Z-0145-2015
    Event ID
    69224
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Parker Laboratories, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    November 5, 2014
    Initiation Date
    August 6, 2014
    Classification Date
    October 28, 2014
    Termination Date
    April 29, 2015
    Address
    286 Eldridge Road, N/A, Fairfield, NJ, 07004-2509, United States

    Description

    Parker Eclipse Probe Cover, Latex Free, REF 38-01, 10 Eclipse Probe Covers, Size: 2.37/1.75"W x 9.5"L (60/44 mm x 241 mm), Lot #D424, Expiry date 04/2016, Pre-gelled inside with Aquasonic 100 Ultrasound Transmission Gel Product Usage: For use as a protective cover for medical ultrasound probes/transducers.

    Reason

    Parker Laboratories, Inc. received a report of an incorrect expiration date on the inner boxes and on the plastic bags of the Eclipse Probe Covers.

    Code Info

    Lot #D424, Part Number PM-038-0224E and BA-046-3801D 4/27/10

    Distribution

    Worldwide Distribution: US (Nationwide) and country of: Canada.

    Quantity

    367 boxes