Recall Z-0510-2022— Compass Health Brands (Corporate Office)
Class II · Ongoing
Class II FDA medical device recall by Compass Health Brands (Corporate Office), initiated 2022-01-10. FDA's recall record names no specific 510(k) clearance for this event. 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: Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including bruising and lacerations requiring stitches..
- Recalling firm
- Compass Health Brands (Corporate Office)
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-01-10
- Firm location
- Middleburg Heights, OH, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.