Events

Recall of Device Recall 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
    52089
  • Event Risk Class
    Class 2
  • Event Number
    Z-1871-2009
  • Event Initiated Date
    2009-05-06
  • Event Date Posted
    2009-09-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82076
  • 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
    Blood Collection Tubes, Vials, Systems, Serum Separators - Product Code JKA
  • Reason
    The two portions of the card are coming apart prematurely.
  • Action
    Whatman issued an Urgent Medical Device Correction letter to to the direct account on 5/6/09 requesting this notice is distributed to users. The notice states the safety issue; requests users to inspect 903 cards prior to use, if the 903 Paper Portion of the card partially or completely detaches from the Demographic portion of the card, discard the card obtain a new card and inspect. On May 26, 2009 the firm expanded the notification to additional users of the 903 cards to inspect cards prior to use.

Device

Device Recall Whatman Body Fluid Collection Paper 903
  • Model / Serial
    Ref:/Lot number: 10534513 WO71 6794508 10534614 WO71 6795508 10534749 WO71 6795908 10534683 WO71 6800708 10534711 WO71 6807908 10534528 WO71 6800108 10534545 WO71 68235.008 10534578 WO71 6825608 10534782 WO71 6798908 10534640 WO71 6803208 10534639 WO71 6820908 10539765 WO71 6821008 10534523 WO71 6800208 10534524 WO71 6800308 10534691 WO71 6824408 10534523 WO71 6824508 10534611 WO71 6824108 10534647 WO71 6803708 10534648 WO71 6803808 10534735 WO71 6796508 10535643 WO71 6806908 10534670 WO71 6806508 10534719 WO71 6810708 10534719 WO71 6824208 10534585 WO71 6801108 10534635 W07l 6802208 10534669 WO71 6796008 10534306 WO71 6799108 10534440 WO71 6199208 10534690 WO71 6800808 10534690 WO71 6616308 10534799 WO71 6826208 10534695 WO71 6811608 10534445 WO71 6812608 10534692 WO71 6812708 10534444 WO71 6812808 10534443 WO71 6812908 10534801 WO71 6813108 10534453 W071 6813208 10534697 WO71 6813308 10534451 WO71 6813408 10534696 WO71 6813508 10534694 WO71 6813608 10534698 WO71 6813708 10535136 WO71 6823308 10534416 WO71 6822908 10534778 WO71 6830909 10534104 W071 6810608 10537853 W071 6602508 10534307 W071 6808508
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- AZ, FL, GA, NC, IL, IN, LA, KS, KY, MI, MO, NE, NY, OH, OK, PA, SC, OR, TX, TN,UT VA, WI, WI, & PR.
  • Product Description
    Whatman Body Fluid Collection Paper 903 || 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