Events

Recall of Device Recall Body Fluid Collection Paper

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
    52101
  • Event Risk Class
    Class 3
  • Event Number
    Z-1005-2010
  • Event Initiated Date
    2009-05-19
  • Event Date Posted
    2010-03-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82094
  • 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
    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.

Device

Device Recall Body Fluid Collection Paper
  • Model / Serial
    Lot Number: W071, Job Numbers: 6797908 and 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, 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.
  • 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