Recall Z-1348-2019 ยท JOW Sleeve, Limb, Compressible
Compass Health Brands (Corporate Office)
MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-S
| Date | Apr 8, 2019 |
| Status | Terminated |
| Reason | Product design change did not receive proper premarket clearance and lacks a 510 (k) |
| Root 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 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974393 | VASO PRESS SYSTEM Britt Corp., Inc., Mar 19, 1999 |