Z-0425-2026 Class II Ongoing
FDA device recall Z-0425-2026 was initiated by Mozarc Medical US LLC on Oct 17, 2025 and is designated Class II. Reason for recall: A potential issue with the seal integrity of header bag packaging. The recall status is ongoing. Affected quantity: 3,258 units.
Recall details
- Product Type
- Devices
- Report Date
- Nov 12, 2025
- Initiation Date
- Oct 17, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,258 units
Product description
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm;
Reason for recall
A potential issue with the seal integrity of header bag packaging.
Distribution pattern
US Nationwide distribution.
Code information
REF Number: 8888102004HP; UDI-DI: (Individual unit) 10884521128002, (Carton) 20884521128009; Lot number: 2424500197;
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0425-2026
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026