Recall Z-0513-2025— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-0513-2025
Creator: U.S. Food and Drug Administration
Published: 2024-10-16

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-10-16. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2024-10-16
Firm location: Northfield, IL, United States

Product description

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

Reason for recall

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

Data sourced from openFDA. This site is unofficial and independent of the FDA.