FDA recall Z-0515-2025

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

MEDLINE procedure kits labeled as follows: 1) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699; 2) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699A

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-0515-2025