Events

Recall of Device Recall UMP Personal Sentry Deluxe Pull String Monitor, Model 91650.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stanley Security Solutions, 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
    60610
  • Event Risk Class
    Class 2
  • Event Number
    Z-1475-2012
  • Event Initiated Date
    2011-12-06
  • Event Date Posted
    2012-04-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105976
  • 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
    Monitor, bed patient - Product Code KMI
  • Reason
    Monitor gives false alarms.
  • Action
    Stanley Healthcare Solutions sent an "IMPORTANT RECALL NOTICE" dated December 8, 2011. The letter identifies the product, problem, and the actions to be taken by the customers. The letter instructs customers to return affected product through Customer Service and to have the appropriate authority sign the Acknowledgement Form. Customers with questions can call UMP Customer Service at 1-800-206-1045.

Device

Device Recall UMP Personal Sentry Deluxe Pull String Monitor, Model 91650.
  • Model / Serial
    P10001 through P11500
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the country of Canada.
  • Product Description
    UMP Personal Sentry Deluxe Pull String Monitor, Model #91650. || The firm on the label is Universal Medical Products, Lincoln, NE. || Designed to sound an alarm when a patient exceeds his or her safe range of movement from a wheelchair, chair, or bed.
  • Manufacturer
    Stanley Security Solutions, Inc.

Manufacturer

Stanley Security Solutions, Inc.
  • Manufacturer Address
    Stanley Security Solutions, Inc., 4600 Vine St, Lincoln NE 68503-2823
  • Manufacturer Parent Company (2017)
    Stanley Black & Decker Inc.
  • Source
    USFDA