Z-1347-2019 Class II Terminated
FDA device recall Z-1347-2019 was initiated by Compass Health Brands (Corporate Office) on April 8, 2019 and is designated Class II. Reason for recall: Product design change did not receive proper premarket clearance and lacks a 510 (k) The recall status is terminated (terminated October 26, 2020).
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 (Short)-Segmental Gradient, Model #6103S-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