Medical Device Recall – April 2019
Products: MediPress Segmental Garments (Lymphedema Sleeves) – accessories for MediPress Pneumatic Compression Lymphedema Pump
Models: #6102-S (half leg), #6103L-S (full leg – Long), #6103M-S (full leg - Medium), #6103S-S (full leg – Short), #6104M-S (full arm - Medium), #6104S-S (full arm – Short)
Affected Serial Numbers: All
Compass Health Brands Corp. is issuing a voluntary recall for the items listed above after it was discovered that a design change did not receive proper premarket clearance as required by Section 510(k) of the Food, Drug, and Cosmetic Act.
Medical Device Field Correction – June 2018
Products: Instructions for Use for REPLACEMENT CUSHION SEALS for Probasics Brand Zzz-Mask SG Full Face CPAP Mask
Models: PB781S, PB781M, PB781L, 781S, 781M and 781L Manufactured After May 2015
Compass Health Brands Corp. has recently identified the need to clarify compatibility information for the replacement cushion seals for the Model# PB7801 Zzz-Mask SG Series Full Face CPAP Mask.