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HomeAMSINO INTERNATIONAL, INC. › AMSafe® 117" (297cm) 60 Drop, 150mL Burette Set (w/15 Micron Filter, Shut-Off)

AMSafe® 117" (297cm) 60 Drop, 150mL Burette Set (w/15 Micron Filter, Shut-Off)

AMSINO INTERNATIONAL, INC. · Model 1 · UDI-DI 10704411004653

FMG Prescription
1
510(k) clearances
6,009
Adverse events (25 deaths)
207
Recalls
84
Facilities

Description

AMSafe® 117" (297cm) 60 Drop, 150mL Burette Set (w/15 Micron Filter, Shut-Off) w/3 MicroClave® Clear, Rotating Luer, Approx Priming Volume: 14.4mL

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
2026-05-12ICU 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
2026-05-12ICU 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
2025-10-29B 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.