BEUDAMED
    FDA Recall 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 · Initiated August 6, 2014

    Recall

    Recall Number
    Z-0145-2015
    Event Number
    69224
    Firm
    Parker Laboratories, Inc.
    FEI Number
    2212018
    Product Code
    IYO
    Status
    Terminated
    Root Cause
    Incorrect or no expiration date
    Initiated
    August 6, 2014
    Posted
    October 29, 2014
    Terminated
    April 29, 2015
    Address
    286 Eldridge Road, Fairfield, NJ, 07004-2509

    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.

    Action

    Parker Laboratories Inc. sent an "Urgent Medical Device Product Recall" Letter/Response Form via Fedex to their customers. The letter indentified the affected product, problem and actions to be taken. For questions contact Parker Laboratories Quality Assurance at 973-276-9500, ext. 7142.

    Distribution

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

    Quantity

    367 boxes