Device product
Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q
Z-2670-2025
Product summary
- Event
- Event 97555
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 828 units
- Official record key
device-enforcement:Z-2670-2025
Official wording
Reason: The kits contain certain lots of cannula products where the catheter may not retain its shape.
Code information: 1) DYNJ0415366P, UDI-DI: 10195327177966(each), 40195327177967(case), Lot Number: 24DMG366; 2) DYNJ0415366Q, UDI-DI: 10195327678227(each), 40195327678228(case), Lot Number: 25EMD672; 3) DYNJ0415366Q, UDI-DI: 10195327678227(each), 40195327678228(case), Lot Number: 25GMD016; 4) DYNJ0415366Q, UDI-DI: 10195327678227(each), 40195327678228(case), Lot Number: 25AMB610; 5) DYNJ0415366Q, UDI-DI: 10195327678227(each), 40195327678228(case), Lot Number: 25BMJ241; 6) DYNJ0415366Q, UDI-DI: 10195327678227(each), 40195327678228(case), Lot Number: 25CMI425; 7) DYNJ0415366Q, UDI-DI: 10195327678227(each), 40195327678228(case), Lot Number: 24DMC189; 8) DYNJ0415366Q, UDI-DI: 10195327678227(each), 40195327678228(case), Lot Number: 24EMC463; 9) DYNJ0415366Q, UDI-DI: 10195327678227(each), 40195327678228(case), Lot Number: 24GMJ353; 10) DYNJ0415366Q, UDI-DI: 10195327678227(each), 40195327678228(case), Lot Number: 24IMB824; 11) DYNJ0415366Q, UDI-DI: 10195327678227(each), 40195327678228(case), Lot Number: 24KME116
Distribution pattern: US Nationwide distribution in the state of CA.
Derived failure modes
-
Unknown
The kits contain certain lots of cannula products where the catheter may not retain its shape.