BEUDAMED
    FDA Recall Terminated

    Whatman Body Fluid Collection Paper- 903 California Newborn Screening Card Ref 110534 903 Card are intended for use by healthcare professionals in the collection and in-vitro storage of neonate human blood. The neonate blood is tested to screen the infant for congenital abnormalities of metabolism and other conditions.790

    Recall: Z-2384-2010 · Initiated October 29, 2009

    Recall

    Recall Number
    Z-2384-2010
    Event Number
    53819
    Firm
    Whatman, Inc.
    FEI Number
    1281317
    Product Code
    JKA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 29, 2009
    Posted
    September 7, 2010
    Terminated
    August 24, 2020
    Address
    63 Community Drive, Sanford, ME, 04073

    Description

    Whatman Body Fluid Collection Paper- 903 California Newborn Screening Card Ref 110534 903 Card are intended for use by healthcare professionals in the collection and in-vitro storage of neonate human blood. The neonate blood is tested to screen the infant for congenital abnormalities of metabolism and other conditions.790

    Reason

    Neonate newborn screening card demographic and filter portion may be detached

    Action

    The firm, Whatman, issued an "URGENT MEDICAL DEVICE CORRECTION" letter dated October 29, 2009, to the customer. The letter described the product, problem and action to be taken by the customer. The letter instructed the customer to: inspect the card and ensure the 903 Paper Portion is firmly and completely fixed to the Demographic portio, prior to recording patient demographic details on the card and obtaining a patient sample; discard the card, obtain a new card and inspect as above, if the 903 Paper Portion of the card partially or completely detaches from the Demographic portion of the card; and to please staple the card stub at two points as specified in the illustration, to prevent any opportunity for 903 paper detachment from the demographic portions. If Whatman customers/users have any questions in relation to this customer notification, please contact, either Product Manager at +1 732 885 6570,email: [email protected] or Quality Assurance at +1 207 459 7557, email: [email protected].

    Distribution

    Nationwide distribution: CA

    Quantity

    488,000 cards