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ProSeal CSTD
EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED · Model 421050VT · UDI-DI 18859299124138
ONB
Prescription
1
510(k) clearances
4,732
Adverse events
71
Recalls
41
Facilities
Description
ProSeal Injector Plus (DMA Compatible)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-24 | ICU Medical, Inc. | Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy |
| 2025-09-08 | ICU Medical, Inc. | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 | ICU Medical, Inc. | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 | ICU Medical, Inc. | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 | ICU Medical, Inc. | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 | ICU Medical, Inc. | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 | ICU Medical, Inc. | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 | ICU Medical, Inc. | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 | ICU Medical, Inc. | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 | ICU Medical, Inc. | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
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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.