FDAFDA · Food and drugs·Recall number Z-1463-2025
Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS
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 DYNJ60655D: UDI/DI 10195327464783 (each), 40195327464784 (case), Lot Number 24AMC692A
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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