FDA recall Z-0510-2022

Compass Health Brands (Corporate Office) · Class II · device

Product

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status: Ongoing
Initiation date: 2022-01-10
Report date: 2022-01-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Middleburg Heights, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0510-2022