Z-0422-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 12, 2025
- Initiation Date
- October 17, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,258 units
Product Description
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;
Reason for Recall
A potential issue with the seal integrity of header bag packaging.
Distribution Pattern
US Nationwide distribution.
Code Information
REF Number: 8888101002HP; UDI-DI: (Individual unit) 10884521127968, (Carton) 20884521127965; Lot number: 2430500017;