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Recall Observatory FDA recall evidence

Device product

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;

Z-1127-2025

November 08, 2024

Class II

Product summary

Firm
Cardinal Health 200, LLC
Event
Event 95947
Status
Ongoing
Classification
Class II
Quantity
973,785 total units
Official record key
device-enforcement:Z-1127-2025

Official wording

Reason: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

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 ;

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.