Z-2515-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2024
- Initiation Date
- April 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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 Pattern
Worldwide distribution.
Code Information
Lot Number 2019072590