Reported Aug 29, 2018 · Terminated
CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L Product Usage: A CPAP mask is attached to an…
Compass Health Brands (Corporate Office)
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Compass Health Brands (Corporate Office) · 6753 Engle Rd · Middleburg Heights, OH · 44130-7934
Is this the product you have?
CPAP Mask CushionModel Nos. PB781SPB781MPB781L781S781M
- and 781L Product UsageA 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
- Lot codes and dates
All units manufactured after May 12015
- Amount recalled
- 742
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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