Drug recall
CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L Product Usage: A CPAP mask is…
FDA recall event 80545 · Class I · Compass Health Brands (Corporate Office)
Key facts
| Event ID | 80545 |
|---|---|
| Recall numbers | Z-2741-2018 |
| Recalling firm | Compass Health Brands (Corporate Office) |
| Product type | Devices |
| Products | 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… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jun 18, 2018 |
| Report date | Aug 29, 2018 |
| Termination date | May 5, 2020 |
| City | Middleburg Heights |
| State | OH |
| Country | United States |
| FEI number | 3012316249 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: