Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0883-04

Minstrel Patient Lift; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model...

Arjo, Inc. / initiated 2003-01-30 / Terminated

Arjo, Inc. began a recall of Minstrel Patient Lift; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model numbers HMB001-US and HMB002-US (with scale) on . The reason FDA records is "The tension pin was not installed in spreader bar pivot bolt to prevent the pivot bolt from migrating out of the spreader bar, allowing the spreader bar to detach from the lift". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0883-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Arjo, Inc.
Product
Minstrel Patient Lift; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model numbers HMB001-US and HMB002-US (with scale)
Product code
FSA Lift, Patient, Non-Ac-Powered
Reason for recall
The tension pin was not installed in spreader bar pivot bolt to prevent the pivot bolt from migrating out of the spreader bar, allowing the spreader bar to detach from the lift.
FDA root cause
Other
Action
All affected end users were given a copy of the Customer Advisory Notice dated 1/30/03, during the Arjo salesmen visits to inspect the Minstrel lifts for the presence of the tension pin in the pivot bolt of the lift. The advisory informed the user of the incident where the spreader bar detached from the scale unit. The end user was requested to read the advisory and sign the bottom portion of it certifying that they read the advisory and that the Arjo salesman inspected their units for the presence of the tension pin, retaining a copy of the signed advisory notice and the inspeciton record.
Quantity in commerce
46 units
Distribution
Nationwide. District of Columbia, New York, Washington, Iowa, Florida, North Carolina, Louisiana, Virginia, South Carolina, Minnesota and Colorado
Product codes and lots
model numbers HMB001-US and HMB002-US, all units with and without scales up to and including serial number MPLA0203A0464