Device product
Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB;
Z-1830-2026
Product summary
- Event
- Event 98599
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 24,170 units
- Official record key
device-enforcement:Z-1830-2026
Official wording
Reason: The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Code information: 1) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25GBK394; 2) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25GBN659; 3) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25GBO446; 4) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25GBO586; 5) DYNJSYR10CWRB, UDI-DI: 10889942540570(each), 40889942540571(case), Lot Number: 25GBQ523
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The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.