Home / Recalls / Compass Health Brands (Corporate Office) / Z-1345-2019

Z-1345-2019 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
May 22, 2019
Initiation Date
April 8, 2019
Termination Date
October 26, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, Model #6104M-S

Reason for Recall

Product design change did not receive proper premarket clearance and lacks a 510 (k)

Distribution Pattern

Domestically to AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TN, KY, TX, UT, VA, WA, WI & WY Internationally to Canada

Code Information

All Serial Numbers/Lots

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-0510-2022 Class II — Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10 (January 10, 2022)
  • 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-1344-2019 Class II — MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, Mod (April 8, 2019)
  • Z-1343-2019 Class II — MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #610 (April 8, 2019)
  • Z-2741-2018 Class I — CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L Pro (June 18, 2018)