Recall Z-2741-2018 ยท BZD Ventilator, Non-Continuous (Respirator)
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.
| Date | Aug 20, 2018 (initiated Jun 18, 2018) |
| Status | Terminated |
| 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 th |
| Quantity | 742 |
| Distribution | US nationwide distribution to AL, CT, FL, GA, KY, MS, NC, NY, TN, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063268 | CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235 Hsiner Co., Ltd., Feb 23, 2007 |