Compass Health Brands (Corporate Office): CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L Product Usage: A CPAP mask is attached to an end user s face and a CPAP machine, to treat end users with sleep apnea. The replacement cushion is a non-durable component that requires replacement every 3 - 6 months. The cushion is used for both comfort and to provide a seal between the face and the mask.

Recall number

Z-2741-2018

Recalling firm

Compass Health Brands (Corporate Office)

Product

CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L Product Usage: A CPAP mask is attached to an end user s face and a CPAP machine, to treat end users with sleep apnea. The replacement cushion is a non-durable component that requires replacement every 3 - 6 months. The cushion is used for both comfort and to provide a seal between the face and the mask.

Status

Terminated

Initiated

2018-06-18

Posted

2018-08-20

Terminated

2020-05-05

Reason

A May 2015 design change in the cushion seal replacement part and accompanying elbow replacement part resulted in incompatibility of the new cushion seal with the previous design of the elbow. Use of the new cushion seal with the previous design elbow could lead to unacceptable CO2 porting. As there was no model number change for this design change, customers may not be aware of the incompatibility.

Root cause

Component change control

Action

On June 19. 2018, the firm sent Urgent Recall Field Correction notices via certified mail. The notice alerted customers to the following product issue: 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. >- A design change made to the cushion seal replacement part (and accompanying elbow replacement part) in May 2015 (18 months prior to Compass Health acquisition of the Pro basics product line) resulted in incompatibility of the new cushion seal with the previous design of the elbow. >- While no complaints or injuries have been reported to-date, use of the new cushion seal with the previous design of elbow could result in unacceptable CO2 porting. >- Since a model number change did not accompany this design change, customers and their consumers would likely not be aware of this incompatibility. Customers were asked to do the following: Ensure all affected personnel are fully informed of this notice. " Forward this notice to your Regulatory Compliance Manager, Purchasing Manager, Customer Service Manager and Field Technicians. " Advise your customers regarding the proper combination of cushion and elbow. The attached consumer communication letter can be used to communicate this information. As noted on the attached consumer communication letter, any consumers who are currently using an incompatible cushion/elbow combination should be instructed to discontinue use of the cushion and elbow and should be instructed to contact their dealer to obtain replacement kits. " Dispose of any current stock you may have of the affected cushion model numbers (PB781S, PB781M, PB781L, 781S, 781M and 781L manufactured after May 2015) and contact Compass Health for replacement kits (NOTE: Full mask model numbers are NOT affected by this recall field correction). " Please contact Compass Health Brands Corp. Customer S

Quantity

742

Distribution

US nationwide distribution to AL, CT, FL, GA, KY, MS, NC, NY, TN, and TX.

Lot, serial or model codes

All units manufactured after May 1, 2015

510(k) numbers

["K063268"]

PMA numbers

not on file

Product code

BZD

Firm FEI

3012316249

Firm city

Middleburg Heights

Firm state

OH

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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