Z-1443-2025 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
- 96 units
Product Description
Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356
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 DYNJ67356: UDI/DI 10193489887136 (each) 40193489887137 (case), Lot number 23GMF016A