Medical device recalls Moderate risk

MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF PAIN1941; 3) TRAY…

Recall date
October 16, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0513-2025
FDA classification
Class II
Brand / firm
MEDLINE INDUSTRIES, LP - Northfield
Sold / distributed
US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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