Recall Z-1344-2019— Compass Health Brands (Corporate Office)

Name: FDA recall Z-1344-2019
Creator: U.S. Food and Drug Administration
Published: 2019-04-08

Class II · Terminated

Class II FDA medical device recall by Compass Health Brands (Corporate Office), initiated 2019-04-08, terminated 2020-10-26. It names one FDA 510(k) clearance: K974393. Product: MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, Model #6103M-S. Reason: Product design change did not receive proper premarket clearance and lacks a 510 (k).

Recalling firm: Compass Health Brands (Corporate Office)
Classification: Class II
Status: Terminated
Initiated: 2019-04-08
Terminated: 2020-10-26
Firm location: Middleburg Heights, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K974393 — VASO PRESS SYSTEMBritt Corp., Inc.·cleared 1999-03-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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)

Data sourced from openFDA. This site is unofficial and independent of the FDA.