FDA recall Z-2515-2024

Product

Centurion procedure kits labeled as NEURO ANGIO PACK, Pack Number DYNDA1431A

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.

Key facts

Status

Ongoing

Initiation date

2024-04-08

Report date

2024-08-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2515-2024