Class 2 Device Recall Compass Health Rollator Mechanical Walker

• Date Initiated by Firm: January 10, 2022
• Create Date: January 19, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0510-2022
• Recall Event ID: 89389
• Product Classification: Walker, mechanical - Product Code ITJ
• 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
• Code Information: Lot/Serial # RM2005000001-RM21004005000 (May 2020 through April 2021 manufacture dates)
• Recalling Firm/ Manufacturer: Compass Health Brands (Corporate Office); 6753 Engle Rd; Middleburg Heights OH 44130-7934
• For Additional Information Contact: SAME; 800-376-7263
• Manufacturer 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.
• FDA Determined 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 parts necessary to complete replacement of the Voyager Rollator casters and axles. 3. A Voyager Caster Installment Guide will be sent as part of the Field Action Kit P/N Voyager Kit and are posted on the Compass Health Brands website. No special certification is required. 4. Complete and return the attached Consumer Field Correction Response Form to Compass Health Brands within fifteen (15) days of receipt of this field correction notification confirming your acknowledgement. Send completed form to Compass Health Brands via email at recall@compasshealthbrands.com. Complete and return this form even if you do not have affected product on hand. 5. Field correction repairs must be completed on affected units before further use of the unit. Distributors: The manufacturer has changed the wheel spoke design to increase the spoke thickness and strength. The manufacturer will supply replacement wheels with the improvement. The improved wheels will be made available to users to replace the existing wheels on the product. 1. Ensure all affected personnel are fully informed of this notice. 2. Forward this notice to your Regulatory Compliance Manager, Purchasing Manager, Customer Service Manager and Field Technicians. 3. The Voyager Rollator casters and axles require replacement. 4. Dealers/distributors or end users should contact Compass Health Brands at (800) 947-1728 and to order replacem
• Quantity in Commerce: 3734 units
• Distribution: Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.