Medical device recalls Moderate risk

Invacare Corporation recalls DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 165…

Recall date
June 15, 2023
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2445-2023
FDA classification
Class II
Brand / firm
Invacare Corporation
Sold / distributed
US Nationwide distribution.

Why it was recalled

Premature failure of the seat during use, the plastic eyelets of the folding mechanism of the device's seat can break, and in a worst-case crossbar also breaks and the Rollator can collapse causing injury to user

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

What was recalled

DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1654807 - DOLOMITE GLOSS 680 ROLLATOR 1655081 - DOLOMITE GLOSS 600 ROLLATOR 1655082 - DOLOMITE GLOSS 520 ROLLATOR 1655083 - DOLOMITE GLOSS 450 ROLLATOR

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