Z-0510-2022 Class II Ongoing
FDA device recall Z-0510-2022 was initiated by Compass Health Brands (Corporate Office) on January 10, 2022 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 3734 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 26, 2022
- Initiation Date
- January 10, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3734 units
Product 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
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 Pattern
Nationwide
Code Information
Lot/Serial # RM2005000001-RM21004005000 (May 2020 through April 2021 manufacture dates)