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Recall Observatory FDA recall evidence

Device product

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

Z-0422-2026

October 17, 2025

Class II

Product summary

Firm
Mozarc Medical US LLC
Event
Event 97848
Status
Ongoing
Classification
Class II
Quantity
3,258 units
Official record key
device-enforcement:Z-0422-2026

Official wording

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

Code information: REF Number: 8888101002HP; UDI-DI: (Individual unit) 10884521127968, (Carton) 20884521127965; Lot number: 2430500017;

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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