FDA-Device2025-11-12Class IIPACKAGING DEFECT
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm;
Hazard
A potential issue with the seal integrity of header bag packaging.
Intended for
Adults
Illnesses reported
None reported
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 Components: 12 Fr/Ch (4.0 mm) x 24 cm;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0425-2026Want us to check the next one for you?
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