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ICU Medical

ICU MEDICAL, INC. · Model MC98067 · UDI-DI 00887709072176

FMG Prescription
1
510(k) clearances
5,928
Adverse events (25 deaths)
205
Recalls
84
Facilities

Description

23" (58 cm) Appx 3.0 ml, Ext Set w/Easydrop Flow Controller, Clave™ Clear, Rotating Luer

Recalls

DateFirmReason
2026-05-21BD SWITZERLAND SARLDue 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
2025-10-29B Braun Medical IncPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29B Braun Medical IncPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29B Braun Medical IncPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29B Braun Medical IncPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29B Braun Medical IncPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29B Braun Medical IncPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29B Braun Medical IncPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29B Braun Medical IncPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29B Braun Medical IncPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

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Data 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.