FDA-Device2024-12-04Class II
MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF PAIN1941; 3) TRAY CON EPID 20G NYL W/TUOHY, REF PAIN9023; 4) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1281 5) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN9024
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
3744 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF PAIN1941; 3) TRAY CON EPID 20G NYL W/TUOHY, REF PAIN9023; 4) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1281 5) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN9024
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0513-2025Don't want to check this manually?
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