FDA-Device2025-11-12Class II
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;
Mozarc Medical US LLC
Hazard
A potential issue with the seal integrity of header bag packaging.
Sold states
US Nationwide distribution.
Affected count
3,258 units
Manufactured in
15 Hampshire St, N/A, Mansfield, MA, United States
Products
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0426-2026Don't want to check this manually?
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