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REPAIR PARTS
SUNSET HEALTHCARE SOLUTIONS, INC. · Model RP014 · UDI-DI 00848530105228
10
510(k) clearances
518
Adverse events (14 deaths)
1
Recalls
230
Facilities
Description
Concentrator Capacitor 15MFD - Platinum Series for IRC5LX, IRC5LXO2, IRCLXAW, IRCSLXO2AW, IRC5LXO2AWQ, IRC9LXO2AP, and IRC5LXAWQ (OEM# 2003019)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-08-10 | A M Systems Inc | Some of the Disposable Smooth Interior Tubing may pull apart when stretched. |
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Get your free API keyRead the docsData 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.