Mozarc Medical US LLC: MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Mozarc Medical US LLC
- Product
- MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;
- Reason / hazard
- A potential issue with the seal integrity of header bag packaging.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution.
- Recall initiated
- 2025-10-17
- Code info
- REF Number: 8888104004HP; UDI-DI: (Individual unit) 10884521832817, (Carton) 20884521128061; Lot number: 2427800166;
- Product quantity
- 3,258 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Mansfield
- State
- MA
- Country
- United States
- Event id
- 97848
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