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Recall Observatory FDA recall evidence

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

Z-0510-2022

January 10, 2022

Class II

Product summary

Firm
Compass Health Brands (Corporate Office)
Event
Event 89389
Status
Ongoing
Classification
Class II
Quantity
3734 units
Official record key
device-enforcement:Z-0510-2022

Official wording

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

Code information: Lot/Serial # RM2005000001-RM21004005000 (May 2020 through April 2021 manufacture dates)

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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