Events

Recall of Whatman Body Fluid Collection Paper 903

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Whatman, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    53819
  • Event Risk Class
    Class 2
  • Event Number
    Z-2384-2010
  • Event Initiated Date
    2009-10-29
  • Event Date Posted
    2010-09-07
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86584
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    tubes, vials, systems, serum separators, blood collection - Product Code JKA
  • 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: lili.lee@ge.com or Quality Assurance at +1 207 459 7557, email: heidi.kuell@ge.com.

Device

Whatman Body Fluid Collection Paper 903
  • Model / Serial
    Lot: W 071 6820708
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: CA
  • Product 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
  • Manufacturer
    Whatman, Inc.

Manufacturer

Whatman, Inc.
  • Manufacturer Address
    Whatman, Inc., 63 Community Drive, Sanford ME 04073
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA