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Standard Closed Suction System
SUNSET HEALTHCARE SOLUTIONS, INC. · Model VEN46001200 · UDI-DI 00848530095796
GCY
Prescription
10
510(k) clearances
4,711
Adverse events (13 deaths)
107
Recalls
215
Facilities
Description
"Standard CSS, Adult, 24-hours, Endotracheal, 540mm, 12Fr, Standard Switch, sterile, latex-"
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. |
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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.