Z-1463-2025 Class II Ongoing
FDA device recall Z-1463-2025 was initiated by MEDLINE INDUSTRIES, LP - Northfield on February 11, 2025 and is designated Class II. 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 pati… The recall status is ongoing. Affected quantity: 1152 units.
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
- 1152 units
Product Description
Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS
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 DYNJ60655D: UDI/DI 10195327464783 (each), 40195327464784 (case), Lot Number 24AMC692A