FDA-Device2025-10-08Class I

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

Hazard

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

Sold states
US Nationwide distribution in the state of CA.
Affected count
828 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model Number: DYNJ0415366Q

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2670-2025

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