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Composite Respiratory Kit: Nationwide Medical

WESTMED, INC. · Model 0837 · UDI-DI 00709078002595

CAT BYX CAW Prescription

510(k) clearances

1,767

Adverse events (30 deaths)

Recalls

263

Facilities

Description

Composite Respiratory Kit: Nationwide Medical 6-0556B, 1-0021B, 1-0014B, 1-0027B, 1-No Smoking Sign, 1-0590B, 1-Cylinder Wrench

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.