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JADA System
Organon LLC · Model JADA-2002 · UDI-DI 00840164521139
OQY
Prescription
1
510(k) clearances
1,341
Adverse events (9 deaths)
2
Recalls
10
Facilities
Description
Vacuum-induced Hemorrhage Control System
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-01-05 | Clinical Innovations, LLC | Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) Lot Number 1214-F-403.) to address the potential for a balloon leak which may affect |
| 2014-12-30 | Clinical Innovations, LLC | Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014. |
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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.