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-1693-2026Original 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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