FDAHealthOctober 17, 2025
Mozarc Medical US LLC — MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
⚠️ A potential issue with the seal integrity of header bag packaging.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 17, 2025
US Nationwide distribution.
What's affected?
- Product
- MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
- Lot code
- 2424500194
Additional details
REF Number: 8888101003HP; UDI-DI: (Individual unit) 10884521127975, (Carton) 20884521127972; Lot number: 2424500194, 2430500018;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 3,258 units.
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