Z-1127-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- February 19, 2025
- Initiation Date
- November 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 973,785 total units
Product Description
Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMD9; 3) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMDX;
Reason for Recall
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
Code Information
1) PN76LMM14, UDI-DI:10888439914467 (each) 50888439914465 (case), Lot Number: J8241D ; 2) PN76LMM14, UDI-DI:10888439914467 (each) 50888439914465 (case), Lot Number: J79Z55 ; 3) PN76LMMD9, UDI-DI:10888439651416 (each) 50888439651414 (case), Lot Number: J4220A ; 4) PN76LMMD9, UDI-DI:10888439651416 (each) 50888439651414 (case), Lot Number: J4220D ; 5) PN76LMMDX, UDI-DI:10888439401318 (each) 50888439401316 (case), Lot Number: J4953F ; 6) PN76LMMDX, UDI-DI:10888439401318 (each) 50888439401316 (case), Lot Number: J46C13 ;