Events

Recall of MoiStir

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Kingswood Laboratories,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
    31780
  • Event Risk Class
    Class 2
  • Event Number
    Z-0820-05
  • Event Initiated Date
    2005-04-22
  • Event Date Posted
    2005-05-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-09-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38492
  • 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
    Saliva, Artificial - Product Code LFD
  • Reason
    Contaminated with aspergillus and penicillum molds.
  • Action
    The firm issued a press release on 4/22/05 instructing consumers to not use the product and to return it to them. Consignees were notified via letter dated 4/22/05.

Device

MoiStir
  • Model / Serial
    Lots A2, 1193, 1209, 1233, 1260 and 1725.
  • Product Classification
    Dental Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Moi-Stir oral swabsticks, an aid to mouth care and oral hygiene, CONTENTS: 3 fibre-tipped swabsticks premoistened with MOI-STIR mouth moistening solutioon and saliva supplement; Product Nos. 55299-703-03 and 55299-703-25. Distributed by Kingswood Laboratories, Inc., Indianapolis, IN 46256-3316. Swabs are sold only in case quantities of 25 foil packs to the carton and 100 foil packs to the case.
  • Manufacturer
    Kingswood Laboratories,Inc

Manufacturer

Kingswood Laboratories,Inc
  • Manufacturer Address
    Kingswood Laboratories,Inc, 10375 Hague Rd, Indianapolis IN 46256-3316
  • Source
    USFDA