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Respiratory Kit

SUNSET HEALTHCARE SOLUTIONS, INC. · Model RESCON005LK · UDI-DI 00848530106294

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

Description

Respiratory Kit - Large 1 kit contains: (4) RES1107, (2) RES012, (1) RES031, (1) RES001, (1) RES3025G, (2) RES050, (1) RES3007F, (1) RES3040G, (2) RES003

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.