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CPAP Kit for DreamStation
SUNSET HEALTHCARE SOLUTIONS, INC. · Model ASHE100CPAPKIT · UDI-DI 00848530093587
10
510(k) clearances
505
Adverse events (14 deaths)
1
Recalls
230
Facilities
Description
(1)TUB06 , (1)CF1010F-1 , (6)CF1010-1
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-08-10 | A M Systems Inc | Some of the Disposable Smooth Interior Tubing may pull apart when stretched. |
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