FDA Medical devices recall · February 19, 2025

Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY recall

Read the official FDA notice ↗

Product

Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110D 3) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA103 4) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10T 5) KIT,CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10U 6) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10X 7) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV2CA10Y 8) SLH AAA PACK, Catalog Number:SCV13AASLA 9) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAF10 10) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH4 11) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH5 12) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH6 13) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH7 14) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH8 15) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFH9 16) MICROVASCULAR FREE FLAP, Catalog Number:SCV30VAFHP 17) MICROVASCULAR FREE FLAP, Catalog Number:SCV30VAFHQ 18) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFHR 19) CALGARY MICROVASCULAR FREEFLAP, Catalog Number:SCV30VAFHS 20) NEURO EMBOLISM PACK, Catalog Number:SNE11AN102 21) NEURO EMBOLISM PACK, Catalog Number:SNE11AN10E

Why was it recalled?

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

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

1) PVV20110B, UDI-DI:10197106291412 (each) 50197106291410 (case), Lot Number: 6788690 ; 2) PVV20110B, UDI-DI:10197106291412 (each) 50197106291410 (case), Lot Number: 6806122 ; 3) PVV20110B, UDI-DI:10197106291412 (each) 50197106291410 (case), Lot Number: 7160517 ; 4) PVV20110D, UDI-DI:10197106546505 (each) 50197106546503 (case), Lot Number: 7287574 ; 5) PVV2CA103, UDI-DI:10888439714081 (each) 50888439714089 (case), Lot Number: J46C12 ; 6) PVV2CA10T, UDI-DI:10888439349467 (each) 50888439349465 (case), Lot Number: J46C11 ; 7) PVV2CA10T, UDI-DI:10888439349467 (each) 50888439349465 (case), Lot Number: J43W16 ; 8) PVV2CA10T, UDI-DI:10888439349467 (each) 50888439349465 (case), Lot Number: J6022K ; 9) PVV2CA10T, UDI-DI:10888439349467 (each) 50888439349465 (case), Lot Number: J7708R ; 10) PVV2CA10T, UDI-DI:10888439349467 (each) 50888439349465 (case), Lot Number: J79Z50 ; 11) PVV2CA10U, UDI-DI:10888439693607 (each) 50888439693605 (case), Lot Number: J8241D ; 12) PVV2CA10U, UDI-DI:10888439693607 (each) 50888439693605 (case), Lot Number: J84K11 ; 13) PVV2CA10X, UDI-DI:10888439967265 (each) 50888439967263 (case), Lot Number: J8998R ; 14) PVV2CA10Y, UDI-DI:10195594175795 (each) 50195594175793 (case), Lot Number: 5140389 ; 15) PVV2CA10Y, UDI-DI:10195594175795 (each) 50195594175793 (case), Lot Number: 5664115 ; 16) PVV2CA10Y, UDI-DI:10195594175795 (each) 50195594175793 (case), Lot Number: 5858468 ; 17) PVV2CA10Y, UDI-DI:10195594175795 (each) 50195594175793 (case), Lot Number: 5858469 ; 18) P

Distribution

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

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-1129-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.