Home › SUNSET HEALTHCARE SOLUTIONS, INC. › Respiratory Accessory
Respiratory Accessory
SUNSET HEALTHCARE SOLUTIONS, INC. · Model VEN66000700M · UDI-DI 00848530096779
GCY
Prescription
10
510(k) clearances
4,706
Adverse events (13 deaths)
107
Recalls
215
Facilities
Description
Standard CSS, Neo/Pediatric, 305mm, 7Fr, Y-Adapter (3-4mm), MDI, sterile, latex-free
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-11-05 | COVIDIEN LLC | The product was released into commercial distribution while subject to importation refusal. |
| 2017-04-21 | Cardinal Health 200, LLC | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. |
| 2017-04-21 | Cardinal Health 200, LLC | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. |
| 2017-04-21 | Cardinal Health 200, LLC | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. |
| 2017-04-21 | Cardinal Health 200, LLC | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. |
| 2017-04-21 | Cardinal Health 200, LLC | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. |
| 2017-04-21 | Cardinal Health 200, LLC | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. |
| 2017-04-21 | Cardinal Health 200, LLC | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. |
| 2017-04-21 | Cardinal Health 200, LLC | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. |
| 2017-04-21 | Cardinal Health 200, LLC | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.