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Terminated

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)

FDA Recall Z-0883-04 · Posted 2004-07-20

Recalling FirmArjo, Inc.
Recall StatusTerminated
Product CodeFSA
Date Initiated2003-01-30
Date Terminated2004-05-12
Product Quantity46 units

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide. District of Columbia, New York, Washington, Iowa, Florida, North Carolina, Louisiana, Virginia, South Carolina, Minnesota and Colorado

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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