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CPAP Accessory

SUNSET HEALTHCARE SOLUTIONS, INC. · Model CAP1027 · UDI-DI 00848530100346

BYX
10
510(k) clearances
505
Adverse events (14 deaths)
1
Recalls
230
Facilities

Description

90-Degree Tubing Elbow for CPAP Machines

Recalls

DateFirmReason
2018-08-10A M Systems IncSome of the Disposable Smooth Interior Tubing may pull apart when stretched.

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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.