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O2 Starter Kit

SUNSET HEALTHCARE SOLUTIONS, INC. · Model RESO2KITHF · UDI-DI 00848530107444

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

Description

O2 Starter Kit - 1 Kit Contains: RES3025G(1), RES1107SHF(2), RES018NS(1), RES050(1), HUM008(1), RES037)1), RES2100(1), RES2102(1), RES003NS(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.