FDA recall Z-1344-2019

Compass Health Brands (Corporate Office) · Class II · device

Product

MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, Model #6103M-S

Reason for recall

Product design change did not receive proper premarket clearance and lacks a 510 (k)

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

Key facts

Status: Terminated
Initiation date: 2019-04-08
Report date: 2019-05-22
Termination date: 2020-10-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Middleburg Heights, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1344-2019