Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

ReTurn 7500/7500 Aid, transfer

FDA Recall Z-0303-2017 · Posted None

Recalling FirmHandicare USA, Inc.
Recall StatusTerminated
Product CodeIKX
Date Initiated2014-04-15
Date Terminated2016-12-13
Product Quantity29 units , plus 47 wing handles were shipped as spare parts

Reason for Recall

During the period of April 2009 May 2011, Handicare AB used a wing handle in which the screw and handle, after repeated tightening, may slide apart. This causes a small amount of play in the attachment of the ladder, which in turn results in high load at the attachment holes of the ladder. Eventually, this may cause mechanical fatigue in the material of the ladder.

Firm Action

Handicare sent a Field Safety notice dated April 21, 2014, to all affected customers. The notification instructed customers to examine the affected ReTurn units for signs of wear and to complete the response form that was mailed with the customer notification letter indicating whether additional parts were required to complete the field correction. For further questions, please call (717) 733-1444.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Distribution to the states of : NY, NJ, NV, NE, IL, CT, PA and ME

Official Source

View FDA Recall →

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

↑