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Recall Observatory FDA recall evidence

Device product

Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q

Z-2670-2025

August 21, 2025

Class I

Product summary

Firm
Medline Industries, LP
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

    reason.no_named_rule · v1.0.0

    The kits contain certain lots of cannula products where the catheter may not retain its shape.