Z-1346-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 22, 2019
- Initiation Date
- April 8, 2019
- Termination Date
- October 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
MediPress pneumatic compression system Full Leg (Long)-Segmental Gradient, Model #6103L-S
Reason for Recall
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Distribution Pattern
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
Code Information
All Serial Numbers/Lots