Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1475-2012

UMP Personal Sentry Deluxe Pull String Monitor, Model #91650. The firm on the label is Universal Medical...

Securitas Healthcare LLC / initiated 2011-12-06 / Terminated / root cause: manufacturing process

Stanley Security Solutions, Inc. began a recall of 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... on . The reason FDA records is "Monitor gives false alarms". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1475-2012
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Securitas Healthcare LLC
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.
Product code
KMI Monitor, Bed Patient
Reason for recall
Monitor gives false alarms
Root cause tag
manufacturing process
FDA root 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.
Product codes and lots
P10001 through P11500