Class 2 Device Recall MediPress Segmental Garments (Lymphedema Sleeves)

• Date Initiated by Firm: April 08, 2019
• Create Date: May 15, 2019
• Recall Status: Terminated on October 26, 2020
• Recall Number: Z-1345-2019
• Recall Event ID: 82629
• 510(K)Number: K974393
• Product Classification: Sleeve, limb, compressible - Product Code JOW
• Product: MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, Model #6104M-S
• Code Information: All Serial Numbers/Lots
• Recalling Firm/ Manufacturer: Compass Health Brands (Corporate Office); 6753 Engle Rd; Middleburg Heights OH 44130-7934
• For Additional Information Contact: 800-376-7263
• Manufacturer Reason for Recall: Product design change did not receive proper premarket clearance and lacks a 510 (k)
• FDA Determined Cause: Device Design
• Action: 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.
• 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JOW