FDA-Device2025-02-05Class II
Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder number STCVC01USGV; general surgical tray
MEDLINE INDUSTRIES, LP - Northfield
Hazard
Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.
Sold states
US Nationwide distribution.
Affected count
749 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7FR 3L 20CM CVC STOCK+ BUNDLE US. Reorder number STCVC01USGV; general surgical tray
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1040-2025Don't want to check this manually?
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