Events

Recall of Papsure, Speculite, Disposable light for vaginal illumination.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Watson Diagnostics 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
    27021
  • Event Risk Class
    Class 2
  • Event Number
    Z-0977-03
  • Event Initiated Date
    2003-08-07
  • Event Date Posted
    2003-08-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29020
  • 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
    Source, Chemiluminescent Light - Product Code MPU
  • Reason
    Lights split, spilling contents when bent to activate.
  • Action
    Users are instructed to cease use and return the product immediately in a letter issued 8/7/2003 return receipt requested.

Device

Papsure, Speculite, Disposable light for vaginal illumination.
  • Model / Serial
    Lot numbers 24C06B, 24C06D, 24C06E, 24D04S.
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Papsure, Speculite, Disposable light for vaginal illumination. 10 packets per box.
  • Manufacturer
    Watson Diagnostics Inc.

Manufacturer

Watson Diagnostics Inc.
  • Manufacturer Address
    Watson Diagnostics Inc., 311 Bonnie Circle, Corona CA 92880
  • Source
    USFDA