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Anesthesia
SUNSET HEALTHCARE SOLUTIONS, INC. · Model AAM1002 · UDI-DI 00848530094959
10
510(k) clearances
115
Adverse events
1
Recalls
161
Facilities
Description
Sunset Anesthesia Mask - Size #2 - Infant
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-09-12 | Engineered Medical Systems,Inc | The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates. |
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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.