FDA recall Z-0513-2025

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 for recall

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

Distribution

US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands

Key facts

Status

Ongoing

Initiation date

2024-10-16

Report date

2024-12-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0513-2025