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

Prism Medical C-Series Carry Bar, Class I, model number 360755. The intended use is a carry bar attached to a C-450 or C-625 ceiling lift used to lift, transfer or position clients.

FDA Recall Z-1578-2013 · Posted 2013-06-21

Recall StatusTerminated
Product CodeFNG
Date Initiated2013-01-27
Date Terminated2018-07-18
Product Quantity1131 carry bars/New England

Reason for Recall

The firm replaced the recalled carry bar with a plastic insert with a carry bar with a metal insert due to improper installation of the recalled carry bars.

Firm Action

The firm, Prism Medical, sent a letter dated January 27, 2013 to is customers.The letter described the product, problem and actions to be taken. The customers were instructed to perform an immediate safety check checking that both the pin and the plug have been inserted into the carry bar as outlined in the attached User Instruction guide. Prism offered to replace the recalled product with a different product with greater functionality. If you have any questions, contact VP-Global Product Development at 416-726-3107.

Root Cause

Use error

Distribution Pattern

Worldwide distribution: US (nationwide) and country of: Canada.

Official Source

View FDA Recall →

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

↑