FDA recall Z-1463-2025

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS

Reason for recall

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Key facts

Status
Ongoing
Initiation date
2025-02-11
Report date
2025-04-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1463-2025