Home / Recalls / Compass Health Brands (Corporate Office) / Z-1398-2023

Z-1398-2023 Class II Ongoing

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

Recall Details

Product Type
Devices
Report Date
April 26, 2023
Initiation Date
March 7, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
30 units

Product Description

REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. Models: DVTREX-U and DVTREX -L

Reason for Recall

Error in the Introduction section of the user manual that indicates the device may be used for the prevention of deep vein thrombosis (DVT). Marketed without a 510k for this indication

Distribution Pattern

Worldwide distribution - US Nationwide and the country of Canada.

Code Information

UDI-DI: DVTREX-L: 00092237622933 DVTREX-U: 00092237622926 All Serial Numbers

Other recalls by Compass Health Brands (Corporate Office)

  • Z-0510-2022 Class II — Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10 (January 10, 2022)
  • 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)