FDA-Device2024-12-04Class II
MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF EPICATH19 2) 20G EPI CATH SINGLE STERILE, REF EPICATH20
MEDLINE INDUSTRIES, LP - Northfield
Hazard
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Sold states
US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands
Affected count
5975 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF EPICATH19 2) 20G EPI CATH SINGLE STERILE, REF EPICATH20
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0510-2025Don't want to check this manually?
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