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ICU Medical
ICU MEDICAL, INC. · Model B3000-46 · UDI-DI 00887709003750
1
510(k) clearances
6,139
Adverse events (25 deaths)
207
Recalls
84
Facilities
Description
84" (213 cm) Appx 13.1 mL, 20 Drop Admin Set with 0.2 Micron Filter, Inj Site, 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 |
| 2026-05-12 | ICU Medical, Inc. | Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with |
| 2026-05-12 | ICU Medical, Inc. | Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material with |
| 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.