FDAFDA · Food and drugs·Recall number Z-1464-2025
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
Published April 2, 2025 · Recall initiated: February 11, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- Worldwide distribution - US Nationwide and the country of Canada.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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