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

Carry bar which is an accessory to a lift used for patients in hospitals and other facilities. Recall impacts the following model numbers: 360741, 360750, 360751, 360755, 360755 Rev B, 360756, and 360757.

FDA Recall Z-0728-2017 · Posted None

Recall StatusTerminated
Product CodeFSA
Date Initiated2016-08-30
Date Terminated2018-07-18
Product Quantitynot greater than 17,964 units

Reason for Recall

The black plastic puck on the carry bar is breaking resulting in potential for patient harm.

Firm Action

The recalling firm sent field safety notices to their customers by mail on August 30, 2016. The notice instructed customers to inspect their carry bar to see if it used a black plastic puck. If it did, they were instructed to contact the recalling firm to receive a metal insert to install. If the puck is cracked or damaged, they can request a new, replacement carry bar at a discounted price. For further questions, please call (866) 891-6502.

Root Cause

Device Design

Distribution Pattern

Distributed US nationwide and to Canada, Japan, Australia, Thailand, Great Britain, and South Korea

Official Source

View FDA Recall →

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

↑