Home / Recalls / Compass Health Brands (Corporate Office) / Z-0510-2022

Z-0510-2022 Class II Ongoing

Recalled by Compass Health Brands (Corporate Office) — Middleburg Heights, OH

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)

Other recalls by Compass Health Brands (Corporate Office)

  • Z-1398-2023 Class II — REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended (March 7, 2023)
  • Z-1343-2019 Class II — MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #610 (April 8, 2019)
  • Z-1348-2019 Class II — MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Mode (April 8, 2019)
  • Z-1346-2019 Class II — MediPress pneumatic compression system Full Leg (Long)-Segmental Gradient, Model (April 8, 2019)
  • Z-1347-2019 Class II — MediPress pneumatic compression system Full Leg (Short)-Segmental Gradient, Mode (April 8, 2019)
  • Z-1345-2019 Class II — MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, Mod (April 8, 2019)
  • Z-1344-2019 Class II — MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, Mod (April 8, 2019)
  • Z-2741-2018 Class I — CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L Pro (June 18, 2018)