MediPress pneumatic compression system Full Leg (Short)-Segmental Gradient, Model #6103S-S
- Recall Initiated
- April 8, 2019
- Terminated
- October 26, 2020
- Recall Number
- Z-1347-2019
- Firm Location
- Middleburg Heights, OH
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
Lot / Code Info
All Serial Numbers/Lots
Root Cause
Device Design
Action Taken
On April 8, 2019 Compass Health issued URGENT MEDICAL DEVICE RECALL notices and Response Forms to customers via courier service. Customers were advised to take the following actions: 1) Ensure all affected personnel are fully informed of this notice. Forward the notice to the Regulatory Compliance Manager, Purchasing Manager, Customer Service Manager and Field Technicians. 2) Advise impacted customers regarding this recall. 3) Immediately check your stock for the model numbers and quarantine all affected product 4) Complete and return the Recall Response Form within fifteen (15) days of receipt of the notice via email to recall@compasshealthbrands.com or via fax to 440-268-2116. Customer with questions may call Compass Health Brands Corp. Customer Support at (800) 376-7263 Monday-Friday 8:00 am EST 5:00 pm EST.