PlainRecalls
FDA Devices Moderate Class II Ongoing

MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF EPICATH19 2) 20G EPI CATH SINGLE STERILE, REF EPICATH20

Reported: December 4, 2024 Initiated: October 16, 2024 #Z-0510-2025

Product Description

MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF EPICATH19 2) 20G EPI CATH SINGLE STERILE, REF EPICATH20

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
5975 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) 20G EPI CATH SINGLE STERILE, REF EPICATH19 2) 20G EPI CATH SINGLE STERILE, REF EPICATH20. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 5975 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-0510-2025.