Recall Z-0510-2022 ยท ITJ Walker, Mechanical
Compass Health Brands (Corporate Office)
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
| Date | Jan 10, 2022 |
| Status | Open, Classified |
| Reason | Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including bruising and lacerations requiring stitches. |
| Root cause | Device Design |
| Action | Compass Health issued Urgent Medical Device recall letter dated January 2022 on 1/11/22 issued to Distributors and Customers via email or hard copy letter. Firm posted recall to their website: https://compasshealthbrands.com/product-recall . Letter states reason for recall, health risk and action to take: Users: Users should stop using the subject products and contact Compass Health Brands. REQUIRED ACTION: 1. The Voyager Rollator casters and axles require replacement. 2. Contact Compass Health Brands at (800) 947 1728 to order replacement kits, P/N Voyager Kit. This kit contains all the par |
| Quantity | 3734 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.