FDA recall Z-0422-2026

Product

MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;

Reason for recall

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

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2025-10-17

Report date

2025-11-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mansfield, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0422-2026