Device product
Medline Kits: 1) D AND C PACK, Model Number: DYNJ41254B
Z-1848-2026
Product summary
- Event
- Event 98599
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 12 units
- Official record key
device-enforcement:Z-1848-2026
Official wording
Reason: The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Code information: 1) DYNJ41254B, UDI-DI: 10888277882003(each), 40888277882004(case), Lot Number: 25FBA224
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The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.