BEUDAMED
    FDA Recall 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 · Initiated February 6, 2013

    Recall

    Recall Number
    Z-1131-2013
    Event Number
    64848
    Firm
    Heritage Labs International LLC
    FEI Number
    1000118383
    Product Code
    KST
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    February 6, 2013
    Posted
    April 18, 2013
    Terminated
    November 25, 2013
    Address
    560 N Rogers Rd, Olathe, KS, 66062-1211

    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.

    Action

    The recalling firm contacted 25 of their 26 customers by phone on February 5, 2013, to notify them of the recall and sent a follow up memo on February 6, 2013, During the call, the firm reminded their customers how many recalled kits they recieved and instructed them to go through the kits and pull the recalled lots. The recalled kits are to be returned to the recalling firm and the firm sent a follow-up memo on February 6, 2013, with the shipping label their customers to place on the returning kit shipping box. This memo was sent to the customers by overnight Fed-ex mail and the ship label for the returned product was an overnight UPS label. On February 7, 2013, the final customer was notified by phone and instructed to return the recalled kits. For further questions please call (913) 764-1045.

    Distribution

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

    Quantity

    25 kits