Z-1449-2025 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
- 268 units
Product Description
Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number DYNJ0665086F; 2) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D; 3) ROBOT LAP TOTAL HYST, Pack Number DYNJ907811A; 4) VAG HYSTE PACK-LF, Pack Number DYNJ0773613J; 5) VAG HYSTERECTOMY PACK-LF, Pack Number DYNJ0549338Q
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 DYNJ0665086F: UDI/DI 10193489395204 (each) 40193489395205 (case), Lot Number 23JBW085A; 2) Pack Number DYNJ0161768D: UDI/DI 10195327107499 (each) 40195327107490 (case), Lot Number 22CDB491A; 3) Pack Number DYNJ907811A: UDI/DI 10193489984170 (each) 40193489984171 (case), Lot Number 21IBP928Z; 4) Pack Number DYNJ0773613J: UDI/DI 10193489863918 (each) 40193489863919 (case), Lot Number 21GMA889A; 5) Pack Number DYNJ0549338Q: UDI/DI 10195327092139 (each) 40195327092130 (case), Lot Number 23EMD924A