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ICU Medical
ICU MEDICAL, INC. · Model Z3807 · UDI-DI 00887709059115
1
510(k) clearances
5,928
Adverse events (25 deaths)
205
Recalls
84
Facilities
Description
6" (15 cm) Appx 0.67 ml, Smallbore Trifuse Ext Set w/3 MicroClave® Clear (Red, Glow, TPN Rings), 0.2 Micron Filter, 3 Clamps, Rotating Luer
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-21 | BD SWITZERLAND SARL | Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has |
| 2025-10-29 | B Braun Medical Inc | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| 2025-10-29 | B Braun Medical Inc | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| 2025-10-29 | B Braun Medical Inc | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| 2025-10-29 | B Braun Medical Inc | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| 2025-10-29 | B Braun Medical Inc | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| 2025-10-29 | B Braun Medical Inc | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| 2025-10-29 | B Braun Medical Inc | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| 2025-10-29 | B Braun Medical Inc | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
| 2025-10-29 | B Braun Medical Inc | Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). |
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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.