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Medium severity

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;

SourceFDA Device Enforcement
CategoryMedical Device
SeverityMedium
Statusongoing
Recall dateOctober 17, 2025
ReportedNovember 12, 2025
Recalling firmMozarc Medical US LLC
Country / regionUnited States MA

Hazard

A potential issue with the seal integrity of header bag packaging.

Affected products

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