BEUDAMED
    FDA Recall Terminated

    AGLH - Lung Health Study, Specimen Collection & Return Kit, Phlebotomy & Urine Kit, Product A2351, 10 kits/shipping carton, each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0 and subassembly collection packs (vacuum bag, spirometry bag, ambient kit inside pouch, blood tube "cold pouch", needle kit). Blood specimen collection

    Recall: Z-0542-2012 · Initiated January 9, 2011

    Recall

    Recall Number
    Z-0542-2012
    Event Number
    57863
    Firm
    Heritage Labs International LLC
    FEI Number
    1000118383
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    January 9, 2011
    Posted
    January 11, 2012
    Terminated
    December 26, 2012
    Address
    560 N Rogers Rd, Olathe, KS, 66062-1211

    Description

    AGLH - Lung Health Study, Specimen Collection & Return Kit, Phlebotomy & Urine Kit, Product A2351, 10 kits/shipping carton, each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0 and subassembly collection packs (vacuum bag, spirometry bag, ambient kit inside pouch, blood tube "cold pouch", needle kit). Blood specimen collection

    Reason

    Kits contain recalled Triad alcohol pads

    Action

    Heritage Labs sent a Device Notification and Safety Alert letter dated January 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Heritage Labs sent replacement alcohol prep pads from a different supplier not affected by the recall to user of Heritage Labs kits. Heritage Labs recommended the replacements be on "as needed" basis. Upon opening kit, users should immediately dispose of sealed TRIAD brand alcohol pads. Users are to use the replacement wipes instead of the wipes contained in the kits. For any questions call (888)764-4120.

    Distribution

    Worldwide Distribution - USA (nationwide) and Germany

    Quantity

    900 kits