FDA-Device2026-04-08Class II

Sterile Radiology Procedure Kits, Model Number DYNDH1491B

Medline Industries, LP
Hazard
There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.
Sold states
US Nationwide distribution in the state of MN.
Affected count
420 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Sterile Radiology Procedure Kits, Model Number DYNDH1491B

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1693-2026

Original summary

Sterile Radiology Procedure Kits, Model Number DYNDH1491B There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility. UDI-DI: (CS) 40198459071455, (EA) 10198459071454; Lot Number: 25GBB924 Distribution: US Nationwide distribution in the state of MN. Affected quantity: 420 units

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