Z-1464-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 2, 2025
- Initiation Date
- February 11, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 422
Product Description
Medline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF, Pack Number DYNJ37741B; 2) ANGIOGRAPHY PACK, Pack Number DYNJ21519W; 3) NEURO ANGIO PACK, Pack Number DYNJ83941; 4) NEURO ANGIO PACK SJF-LF, Pack Number DYNJ55678; 5) NEURO PACK, Pack Number DYNJ04851Q; 6) SNI NEURO, Pack Number DYNJ45379D; 7) VP SHUNT PACK, Pack Number DYNJ55558C
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 - US Nationwide and the country of Canada.
Code Information
1) Pack Number DYNJ37741B: UDI/DI (each) 40193489682213 (case), Lot Number 20BDB113A; 2) Pack Number DYNJ21519W: UDI/DI (each) 40889942255611 (case), Lot Number 20BDB225A; 3) Pack Number DYNJ83941: UDI/DI (each) 40888277736574 (case), Lot Number 22JBA879Z; 4) Pack Number DYNJ55678: UDI/DI (each) 40193489468688 (case), Lot Number 22JBC551Z; 5) Pack Number DYNJ04851Q: UDI/DI (each) 40889942402176 (case), Lot Number 22JBC798Z; 6) Pack Number DYNJ45379D: UDI/DI (each) 40195327048748 (case), Lot Number 23FME560A; 7) Pack Number DYNJ55558C: UDI/DI (each) 40195327408214 (case), Lot Number 23LMG468A