MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-S
Reported: May 22, 2019 Initiated: April 8, 2019 #Z-1348-2019
Product Description
MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-S
Reason for Recall
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Details
- Recalling Firm
- Compass Health Brands (Corporate Office)
- Distribution
- 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
- Location
- Middleburg Heights, OH
Frequently Asked Questions
What product was recalled? ▼
MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-S. Recalled by Compass Health Brands (Corporate Office).
Why was this product recalled? ▼
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 22, 2019. Severity: Moderate. Recall number: Z-1348-2019.
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