Device product
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
Z-0424-2026
Product summary
- Event
- Event 97848
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3,258 units
- Official record key
device-enforcement:Z-0424-2026
Official wording
Reason: A potential issue with the seal integrity of header bag packaging.
Code information: REF Number: 8888102003HP; UDI-DI: (Individual unit) 10884521127999, (Carton) 20884521127996; Lot number: 2418000195;
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
A potential issue with the seal integrity of header bag packaging.