BEUDAMED
    FDA Recall Terminated

    Whatman Body Fluid Collection Paper 903, Ref: 10534790, for IVD use. Whatman Inc., Florham Park, NJ. The device is used by healthcare professionals in the collection and in-vitro storage of neonate blood.

    Recall: Z-1005-2010 · Initiated May 19, 2009

    Recall

    Recall Number
    Z-1005-2010
    Event Number
    52101
    Firm
    Whatman, Inc.
    FEI Number
    1281317
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 19, 2009
    Posted
    March 5, 2010
    Terminated
    September 28, 2015
    Address
    63 Community Drive, Sanford, ME, 04073

    Description

    Whatman Body Fluid Collection Paper 903, Ref: 10534790, for IVD use. Whatman Inc., Florham Park, NJ. The device is used by healthcare professionals in the collection and in-vitro storage of neonate blood.

    Reason

    '903' newborn Neonate screening cards have duplicate numbers assigned on cards and may result in cross-over of patient test results

    Action

    Whatman issued an "Urgent Medical Device Correction " letter on May 19, 2009. The consignee was instructed to remove cards with duplicate numbers. For further information, contact Whatman Inc. Quality Assurance at 1-207-459-7557.

    Distribution

    Nationwide Distribution -- CA.

    Quantity

    11,300 Cards