FDA-Device2024-08-14Class II

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

Hazard

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.

Sold states
Worldwide distribution.
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Centurion procedure kits labeled as NEURO ANGIO PACK, Pack Number DYNDA1431A

Official notice

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

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