FDA recall Z-1393-2025

Product

Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098

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 - US Nationwide and the country of Canada.

Key facts

Status

Ongoing

Initiation date

2025-02-11

Report date

2025-03-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1393-2025