Compass Health Brands (Corporate Office) recalls MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-S
- Recall date
- April 8, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1343-2019
- FDA classification
- Class II
- Brand / firm
- Compass Health Brands (Corporate Office)
- Sold / distributed
- 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
Why it was recalled
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-S
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