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U.S. Department of Health and Human Services

Class 1 Device Recall CPAP Mask Cushion

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  Class 1 Device Recall CPAP Mask Cushion see related information
Date Initiated by Firm June 18, 2018
Date Posted August 20, 2018
Recall Status1 Terminated 3 on May 05, 2020
Recall Number Z-2741-2018
Recall Event ID 80545
510(K)Number K063268  
Product Classification Ventilator, non-continuous (respirator) - Product Code BZD
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.
Code Information All units manufactured after May 1, 2015
Recalling Firm/
Manufacturer		 Compass Health Brands (Corporate Office)
6753 Engle Rd
Middleburg Heights OH 44130-7934
For Additional Information Contact Compass Health Brands Customer Support
800-376-7263
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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 in Commerce 742
Distribution US nationwide distribution to AL, CT, FL, GA, KY, MS, NC, NY, TN, and TX.
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 = BZD and Original Applicant = HSINER CO., LTD.
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