Class 2 Device Recall UMP Personal Sentry Deluxe Pull String Monitor, Model 91650.

• Date Initiated by Firm: December 06, 2011
• Date Posted: April 27, 2012
• Recall Status: Terminated on September 24, 2013
• Recall Number: Z-1475-2012
• Recall Event ID: 60610
• Product Classification: Monitor, bed patient - Product Code KMI
• Product: 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.
• Code Information: P10001 through P11500
• Recalling Firm/ Manufacturer: Stanley Security Solutions, Inc.; 4600 Vine St; Lincoln NE 68503-2823
• For Additional Information Contact: Gina L. Bennett; 407-271-2097
• Manufacturer Reason for Recall: Monitor gives false alarms
• FDA Determined Cause: Nonconforming Material/Component
• 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.
• Quantity in Commerce: 592 units
• Distribution: Worldwide Distribution-USA (nationwide) and the country of Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.