Recall Z-2741-2018— Compass Health Brands (Corporate Office)

Name: FDA recall Z-2741-2018
Creator: U.S. Food and Drug Administration
Published: 2018-06-18

Class I · Terminated

Class I FDA medical device recall by Compass Health Brands (Corporate Office), initiated 2018-06-18, terminated 2020-05-05. It names one FDA 510(k) clearance: K063268. 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.. 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..

Recalling firm: Compass Health Brands (Corporate Office)
Classification: Class I
Status: Terminated
Initiated: 2018-06-18
Terminated: 2020-05-05
Firm location: Middleburg Heights, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K063268 — CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235Hsiner Co., Ltd.·cleared 2007-02-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.