Z-1435-2025 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
- 340 units
Product Description
Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A; 2) PAIN MANAGEMENT TRAY-LF, Pack Number DYNJRA1749
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 DYNJRA0869A, 10889942531059 (each) 40889942531050 (case), Lot Number 20KBD382A; 2) Pack Number DYNJRA1749, 10193489829273 (each) 40193489829274 (case), Lot Number 24CMF477A