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Oxygen Kit

SUNSET HEALTHCARE SOLUTIONS, INC. · Model AOCH002RESO2KIT · UDI-DI 00848530107277

OGL
0
510(k) clearances
13
Adverse events
1
Recalls
15
Facilities

Description

Oxygen Kit - This kit contains: RES1107S (4), RES3025G (2), RES037 (2), RES018 (2), RES003 (2), RES050 (2), and RES002 (1)

Recalls

DateFirmReason
2011-10-17Vital Signs Devices, a GE Healthcare CompanyPovidone Iodine Pads included in the Vital Signs Broselow Pediatric Emergency Kit may be contaminated with Elizabethkinga meningoseptica.

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Data 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.