TiSport, Llc recalls TiLite X-Short anti-tip tubes, models TRA, AERO T, ZRA, AERO Z, 2GX, AERO X, Twist, and AERO R, a component of the TiLi…

Recall date

September 11, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2294-2019

FDA classification

Class II

Brand / firm

TiSport, Llc

Sold / distributed

Distribution was nationwide, including Puerto Rico. There was also government distribution but no military distribution. Foreign distribution was made to Canada, Australia, Brazil, China, Italy, Saudi Arabia, Switzerland, United Kingdom, and Uruguay.

Why it was recalled

The anti-tip tubes potentially fail in certain situations and the wheelchairs can tip backwards.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

TiLite X-Short anti-tip tubes, models TRA, AERO T, ZRA, AERO Z, 2GX, AERO X, Twist, and AERO R, a component of the TiLite wheelchair (anti-tip extension for manual wheelchairs). Product Usage: The affected component is part of a manual wheelchair to provide mobility to physically impaired individuals. The affected component is used to prevent the wheelchair from tipping backwards.