Device product
Medline Kits: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C; 2) SLING PACK, Model Number: DYNJ62849B
Z-1847-2026
Product summary
- Event
- Event 98599
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 89 units
- Official record key
device-enforcement:Z-1847-2026
Official wording
Reason: The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Code information: 1) DYNJ48399C, UDI-DI: 10195327172626(each), 40195327172627(case), Lot Number: 24CBU779; 2) DYNJ62849B, UDI-DI: 10195327514884(each), 40195327514885(case), Lot Number: 24BBS275
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The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.