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OXYGEN KIT
SUNSET HEALTHCARE SOLUTIONS, INC. · Model APRO063O2KIT2 · UDI-DI 00848530107505
10
510(k) clearances
518
Adverse events (14 deaths)
1
Recalls
230
Facilities
Description
OXYGEN KIT CONTAINS - (2) RES1107S, (1) RES3025, (1) RES050, (1) RES012NS, and (1) RES003NS
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.