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O2 Kit

SUNSET HEALTHCARE SOLUTIONS, INC. · Model AGLA001DME02KIT · UDI-DI 00848530093464

CAT

510(k) clearances

1,798

Adverse events (30 deaths)

Recalls

264

Facilities

Description

(4)RES1104S, (5)RES1107S, (4)RES018NS, (5)RES3015G, (2)RES050NS, (2)RES037, (2) HUM008

Recalls

Date	Firm	Reason
2018-07-06	Smiths Medical ASD Inc.	"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
2018-07-06	Smiths Medical ASD Inc.	"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
2018-07-06	Smiths Medical ASD Inc.	"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
2018-07-06	Smiths Medical ASD Inc.	"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
2018-07-06	Smiths Medical ASD Inc.	"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
2017-05-09	Teleflex Medical	Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult device.

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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.