MediPress pneumatic compression system Full Arm recall
MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-S
Why was MediPress pneumatic compression system Full Arm recalled?
Product design change did not receive proper premarket clearance and lacks a 510 (k)
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Serial Numbers/Lots
- Product
- MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-S
- 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
- Recall date
- May 22, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)