MediPress pneumatic compression system Full Leg (Long)-Segmental Gradient, Model #6103L-S
Class I - DangerousWhat Should You Do?
- Check if you have this product: All Serial Numbers/Lots
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Compass Health Brands (Corporate Office)
- Reason for Recall:
- Product design change did not receive proper premarket clearance and lacks a 510 (k)
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
MediPress pneumatic compression system Full Leg (Long)-Segmental Gradient, Model #6103L-S
Product Codes/Lot Numbers:
All Serial Numbers/Lots
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1346-2019
Related Recalls
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
Compass Health Brands (Corporate Office)
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
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
Compass Health Brands (Corporate Office)
Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including bruising and lacerations requiring stitches.
MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-S
Compass Health Brands (Corporate Office)
Product design change did not receive proper premarket clearance and lacks a 510 (k)