BEUDAMED
    FDA Enforcement Class II Terminated

    5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the order of a physician. Probe cover

    Recall: Z-0974-2014 · Reported February 19, 2014

    Enforcement

    Recall Number
    Z-0974-2014
    Event ID
    65753
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Custom Medical Specialties, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 19, 2014
    Initiation Date
    July 12, 2013
    Classification Date
    February 12, 2014
    Termination Date
    April 8, 2014
    Address
    330 East Main Street, N/A, Pine Level, NC, 27568, United States

    Description

    5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the order of a physician. Probe cover

    Reason

    No endotoxin (LAL) testing to proper level.

    Code Info

    Microtek/Ecolab Lot Nos. D91821, D92081, D92301, D93411, D100891, D101981, D102461, D103081, D103081A, D103331, D110871, D111021, D113551, D121521 - Custom Medical Lot Nos. 15831-0906, Exp. 6/2012; 17181-0910, Exp. 1/2012; 17926-1001, Exp. 1/2013; 18672-1003, Exp. 3/2013; 19067-104, Exp. 4/2013; 19683-1005, Exp. 5/2013; 19771-1006, Exp. 6/2013; 19931-1006, Exp. 6/2013; 21886-1010, Exp. 10/2013; 23233-1103, Exp. 3/2014; 24926-1108, Exp. 8/2014; 25201-1109, Exp. 9/2014; 26150-1112, Exp. 12/2014; 26502-1201, Exp. 1/2015; 27522-1204, Exp. 4/2015; 28161-1206, Exp. 6/2015; 28999-1208, Exp. 8/2015; 29153-1208, Exp. 8/2015; 31811-1304, Exp. 4/2016; 32056-1305, Exp. 5/2016; 32391-1306, Exp. 6/2016

    Distribution

    US Distribution including the states of CT, FL, IL, NJ, NY, PA, TN, VA and WI.

    Quantity

    2,610