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ICU Medical

ICU MEDICAL, INC. · Model B31748 · UDI-DI 00887709077232

FMG Prescription

510(k) clearances

6,009

Adverse events (25 deaths)

207

Recalls

Facilities

Description

108" (274 cm) Appx 19.9 ml, 60 Drop Primary Set, Rotating Luer w/Filter Cap

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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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.