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Compass Health Brands (Corporate Office) Recall 89389

Description: 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

Compass Health Brands (Corporate Office) Recall 89389 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0510-2022
Event ID89389
Event DescriptionVoyager 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
Product TypeDevices
DistributionNationwide
Quantity3734 units
Recall ReasonWheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including bruising and lacerations requiring stitches.
Device Classification20220126
Device Code InfoLot/Serial # RM2005000001-RM21004005000 (May 2020 through April 2021 manufacture dates)
Center Classification Date20220119
Recall Initiation Date20220110
Recalling FirmCompass Health Brands (Corporate Office)
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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