Device product
Medline Kits: 1) PICC TRAY, Model Number: DYNJ41648A
Z-1837-2026
Product summary
- Event
- Event 98599
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 20 units
- Official record key
device-enforcement:Z-1837-2026
Official wording
Reason: The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Code information: 1) DYNJ41648A, UDI-DI: 10198459062834(each), 40198459062835(case), Lot Number: 25CLA242; 2) DYNJ41648A, UDI-DI: 10198459062834(each), 40198459062835(case), Lot Number: 24LLA758
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.