PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: December 4, 2024 Initiated: October 16, 2024 #Z-0513-2025

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.

Details

Units Affected
3744 units
Distribution
US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands
Location
Northfield, IL

Frequently Asked Questions

What product 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. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 3744 units.
Why was this product recalled?
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 4, 2024. Severity: Moderate. Recall number: Z-0513-2025.