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Recall Observatory FDA recall evidence

Device product

Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFB 3) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFC

Z-1133-2025

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-1133-2025

Official wording

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

Code information: 1) PB4FRHWFA, UDI-DI:10197106527009 (each) 50197106527007 (case), Lot Number: 6701856 ; 2) PB4FRHWFA, UDI-DI:10197106527009 (each) 50197106527007 (case), Lot Number: 7331357 ; 3) PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7266123 ; 4) PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7331357 ; 5) PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7333452 ; 6) PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7333453 ; 7) PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7160530 ; 8) PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7333452 ; 9) PB4FRHWFC, UDI-DI:10197106732311 (each) 50197106732319 (case), Lot Number: 7350003 ;

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.