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U.S. Department of Health and Human Services

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

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 Class 2 Recall
UMP Personal Sentry Deluxe Pull String Monitor, Model 91650.
see related information
Date Posted April 27, 2012
Recall Status1 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, Nebraska 68503-2823
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Gina L. Bennett
407-271-2097
Manufacturer Reason
for Recall
Monitor gives false alarms
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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