Medical device recalls Moderate risk

Compass Health Brands (Corporate Office) product recalled over laceration hazard

Recall date
January 10, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Compass Health Brands (Corporate Office) recalls Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager…
Recall number
Z-0510-2022
FDA classification
Class II
Brand / firm
Compass Health Brands (Corporate Office)
Sold / distributed
Nationwide

Why it was recalled

Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including bruising and lacerations requiring stitches.

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

What was recalled

Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager Rollator Cobalt Blue UPC: 815067078066; RLEU10PK Voyager Rollator Rose Gold UPC: 815067078073; RLEU10WT Voyager Rollator Ice Palace UPC: 815067078080

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