BEUDAMED
    FDA Enforcement Class II Terminated

    Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3 zippered plastic bags which hold support supplies for health care providers when treating patients. Bag #3 contains 5 different blood collection tubes (5 each) and 2 different gauge needles--all for drawing blood. One of the tubes is the recalled BD blue top citrate tube (5 tubes). These tubes were manufactured by BD, Franklin Lakes, NJ. The kit is used by health care providers when treating patients.

    Recall: Z-1131-2013 · Reported April 24, 2013

    Enforcement

    Recall Number
    Z-1131-2013
    Event ID
    64848
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Heritage Labs International LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 24, 2013
    Initiation Date
    February 6, 2013
    Classification Date
    April 18, 2013
    Termination Date
    November 25, 2013
    Address
    560 N Rogers Rd, N/A, Olathe, KS, 66062-1211, United States

    Description

    Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3 zippered plastic bags which hold support supplies for health care providers when treating patients. Bag #3 contains 5 different blood collection tubes (5 each) and 2 different gauge needles--all for drawing blood. One of the tubes is the recalled BD blue top citrate tube (5 tubes). These tubes were manufactured by BD, Franklin Lakes, NJ. The kit is used by health care providers when treating patients.

    Reason

    The product has a Lithium Heparin contaminant which could adversely affect coagulation results potentially causing erroneous lab results.

    Code Info

    Lot A2376-12307, exp 2/28/2013 and Lot A2376-12272, exp 4/30/2013

    Distribution

    Nationwide Distribution including the states of AL, CA, GA, IL, IN, KY, MA, MD, NC, NY, OK and VA.

    Quantity

    25 kits