← FDA ENFORCEMENT
Z-0421-2026Class II

Mozarc Medical US LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Mozarc Medical US LLC
Product type
Device
Status
Ongoing
Report date
2025-11-12
Distribution
US Nationwide distribution.
Firm state
MA
Product quantity
3,258 units
Initiated by
Voluntary: Firm initiated
Reason for recall

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

Product description

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

Code / lot info

REF Number: 8888101001HP; UDI-DI: (Individual unit) 10884521127890, (Carton) 20884521127897; Lot number: 2430500021

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →