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CPAP Masks

SUNSET HEALTHCARE SOLUTIONS, INC. · Model CM205M · UDI-DI 00848530097561

BZN Prescription

510(k) clearances

141

Adverse events (1 deaths)

Recalls

134

Facilities

Description

Sunset Sol Full Face CPAP Mask with Medium Frame and Cushion, Headgear and SHS Labeled Bag

Recalls

Date	Firm	Reason
2019-04-23	Stryker Corporation	There is a potential problem with firm s Connected OR Cart, 120V resulting in cart monitor not attaching flush with their monitor stow handle. The product is not manufactured to sp
2013-08-30	Stryker Endoscopy	When positioning the display located on top of the video cart, it is possible for the user to apply excessive force and push the display up and out of the mounting arm. This can re

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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.