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Oxygen Kit
SUNSET HEALTHCARE SOLUTIONS, INC. · Model APR001SFTO2KIT · UDI-DI 00848530108434
0
510(k) clearances
13
Adverse events
1
Recalls
15
Facilities
Description
Oxygen Kit (6- RES1107S, 1- RES3050G,2- RES012, 2 -RES001)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-10-17 | Vital Signs Devices, a GE Healthcare Company | Povidone Iodine Pads included in the Vital Signs Broselow Pediatric Emergency Kit may be contaminated with Elizabethkinga meningoseptica. |
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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.