FDAFDA · Food and drugs·Recall number Z-1343-2019
MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-S
Published May 22, 2019 · Recall initiated: April 8, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Product design change did not receive proper premarket clearance and lacks a 510 (k)
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Compass Health Brands (Corporate Office)
- Distributor
- 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
- Lot
- All Serial Numbers/Lots
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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