CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L Product Usage: A CPAP mask is attached to an e

FDA device recall Z-2741-2018 · posted 2018-08-20 · Terminated

Recall details

Recalling firm

Compass Health Brands (Corporate Office)

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.

Action taken

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

Root cause

Component change control

Status

Terminated

Product code

BZD

Quantity affected

742

Distribution

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

Date initiated

2018-06-18

Date posted

2018-08-20

Date terminated

2020-05-05

Location

Middleburg Heights, OH

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