FDA-Device2025-04-23Class II
Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK, Model Number: DYNJHTCAD1; 2) ANGIOGRAPHY TRAY-LF, Model Number: DYNJ05350V; 3) ANGIOGRAPHY PACK, Model Number: DYNJ38144C
MEDLINE INDUSTRIES, LP - Northfield
Hazard
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.
Affected count
2,118 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK, Model Number: DYNJHTCAD1; 2) ANGIOGRAPHY TRAY-LF, Model Number: DYNJ05350V; 3) ANGIOGRAPHY PACK, Model Number: DYNJ38144C
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1590-2025Don't want to check this manually?
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