FDA Device Intelligence
HomeICU MEDICAL, INC. › ICU Medical

ICU Medical

ICU MEDICAL, INC. · Model MRSA60-120 · UDI-DI 00887709079489

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

Description

120" (305 cm) 60 Drop, Vented/Non-Vented Gravity Admin Set w/MicroClave™ Clear, Pre-Slit Port, Rotating Luer, Approx Priming Volume: 15.2 mL

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).

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.