Recall archive / FDA device enforcement

Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Number:PVV20110B; 2) KIT, CAROTID ENDARTERECT... — FDA record Z-1129-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Nov 8, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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
Reason: Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Classification: Class II
Recalling firm: Cardinal Health 200, LLC
Quantity: 973,785 total units
Agency-reported status: Ongoing
Source record identifier: Z-1129-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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) PVV2CA10Y, UDI-DI:10195594175795 (each) 50195594175793 (case), Lot Number: 6116189 ; 19) PVV2CA10Y, UDI-DI:10195594175795 (each) 50195594175793 (case), Lot Number: 6251075 ; 20) SCV13AASLA, UDI-DI:10197106514481 (each) 50197106514489 (case), Lot Number: 7055826 ; 21) SCV13AASLA, UDI-DI:10197106514481 (each) 50197106514489 (case), Lot Number: 7287469 ; 22) SCV13AASLA, UDI-DI:10197106514481 (each) 50197106514489 (case), Lot Number: 7331456 ; 23) SCV13AASLA, UDI-DI:10197106514481 (each) 50197106514489 (case), Lot Number: 7332825 ; 24) SCV30VAF10, UDI-DI:10197106231142 (each) 50197106231140 (case), Lot Number: 6702001 ; 25) SCV30VAFH4, UDI-DI:10195594091989 (each) 50195594091987 (case), Lot Number: J8045P ; 26) SCV30VAFH5, UDI-DI:10195594154073 (each) 50195594154071 (case), Lot Number: 5138326 ; 27) SCV30VAFH6, UDI-DI:10195594243616 (each) 50195594243614 (case), Lot Number: J9699Y ; 28) SCV30VAFH7, UDI-DI:10195594324940 (each) 50195594324948 (case), Lot Number: 5405620 ; 29) SCV30VAFH8, UDI-DI:10195594381400 (each) 50195594381408 (case), Lot Number: 5138335 ; 30) SCV30VAFH9, UDI-DI:10195594616182 (each) 50195594616180 (case), Lot Number: D212939 ; 31) SCV30VAFH9, UDI-DI:10195594616182 (each) 50195594616180 (case), Lot Number: 5775803 ; 32) SCV30VAFHP, UDI-DI:10888439248883 (each) 50888439248881 (case), Lot Number: J3986T ; 33) SCV30VAFHP, UDI-DI:10888439248883 (each) 50888439248881 (case), Lot Number: J4219R ; 34) SCV30VAFHP, UDI-DI:10888439248883 (each) 50888439248881 (case), Lot Number: J4877C ; 35) SCV30VAFHQ, UDI-DI:10888439785494 (each) 50888439785492 (case), Lot Number: J6278H ; 36) SCV30VAFHQ, UDI-DI:10888439785494 (each) 50888439785492 (case), Lot Number: J6786K ; 37) SCV30VAFHQ, UDI-DI:10888439785494 (each) 50888439785492 (case), Lot Number: J76N07 ; 38) SCV30VAFHR, UDI-DI:10888439928877 (each) 50888439928875 (case), Lot Number: J86N63 ; 39) SCV30VAFHR, UDI-DI:10888439928877 (each) 50888439928875 (case), Lot Number: J86N65 ; 40) SCV30VAFHR, UDI-DI:10888439928877 (each) 50888439928875 (case), Lot Number: J70X09 ; 41) SCV30VAFHR, UDI-DI:10888439928877 (each) 50888439928875 (case), Lot Number: J9424P ; 42) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 7332861 ; 43) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6701998 ; 44) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6748352 ; 45) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6748352 ; 46) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6470289 ; 47) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6775068 ; 48) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6775065 ; 49) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 7005466 ; 50) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 7280092 ; 51) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 7280093 ; 52) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 7005463 ; 53) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 7332855 ; 54) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6022069 ; 55) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6133658 ; 56) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6232003 ; 57) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6345513 ; 58) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6416679 ; 59) SNE11AN102, UDI-DI:10197106232293 (each) 50197106232291 (case), Lot Number: 6568688 ; 60) SNE11AN10E, UDI-DI:10197106067062 (each) 50197106067060 (case), Lot Number: 6560950 ;

Label field

Details supplied by the agency

Lot, code or applicability

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) PVV2CA10Y, UDI-DI:10195594175795 (each) 50195594175793 (case), Lot Number: 6116189 ; 19) PVV2CA10Y, UDI-DI:10195594175795 (each) 50195594175793 (case), Lot Number: 6251075 ; 20) SCV13AASLA, UDI-DI:10197106514481 (each) 50197106514489 (case), Lot Number: 7055826 ; 21) SCV13AASLA, UDI-DI:10197106514481 (each) 50197106514489 (case), Lot Number: 7287469 ; 22) SCV13AASLA, UDI-DI:10197106514481 (each) 50197106514489 (case), Lot Number: 7331456 ; 23) SCV13AASLA, UDI-DI:10197106514481 (each) 50197106514489 (case), Lot Number: 7332825 ; 24) SCV30VAF10, UDI-DI:10197106231142 (each) 50197106231140 (case), Lot Number: 6702001 ; 25) SCV30VAFH4, UDI-DI:10195594091989 (each) 50195594091987 (case), Lot Number: J8045P ; 26) SCV30VAFH5, UDI-DI:10195594154073 (each) 50195594154071 (case), Lot Number: 5138326 ; 27) SCV30VAFH6, UDI-DI:10195594243616 (each) 50195594243614 (case), Lot Number: J9699Y ; 28) SCV30VAFH7, UDI-DI:10195594324940 (each) 50195594324948 (case), Lot Number: 5405620 ; 29) SCV30VAFH8, UDI-DI:10195594381400 (each) 50195594381408 (case), Lot Number: 5138335 ; 30) SCV30VAFH9, UDI-DI:10195594616182 (each) 50195594616180 (case), Lot Number: D212939 ; 31) SCV30VAFH9, UDI-DI:10195594616182 (each) 50195594616180 (case), Lot Number: 5775803 ; 32) SCV30VAFHP, UDI-DI:10888439248883 (each) 50888439248881 (case), Lot Number: J3986T ; 33) SCV30VAFHP, UDI-DI:10888439248883 (each) 50888439248881 (case), Lot Number: J4219R ; 34) SCV30VAFHP, UDI-DI:10888439248883 (each) 50888439248881 (case), Lot Number: J4877C ; 35) SCV30VAFHQ, UDI-DI:10888439785494 (each) 50888439785492 (case), Lot Number: J6278H ; 36) SCV30VAFHQ, UDI-DI:10888439785494 (each) 50888439785492 (case), Lot Number: J6786K ; 37) SCV30VAFHQ, UDI-DI:10888439785494 (each) 50888439785492 (case), Lot Number: J76N07 ; 38) SCV30VAFHR, UDI-DI:10888439928877 (each) 50888439928875 (case), Lot Number: J86N63 ; 39) SCV30VAFHR, UDI-DI:10888439928877 (each) 50888439928875 (case), Lot Number: J86N65 ; 40) SCV30VAFHR, UDI-DI:10888439928877 (each) 50888439928875 (case), Lot Number: J70X09 ; 41) SCV30VAFHR, UDI-DI:10888439928877 (each) 50888439928875 (case), Lot Number: J9424P ; 42) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 7332861 ; 43) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6701998 ; 44) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6748352 ; 45) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6748352 ; 46) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6470289 ; 47) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6775068 ; 48) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6775065 ; 49) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 7005466 ; 50) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 7280092 ; 51) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 7280093 ; 52) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 7005463 ; 53) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 7332855 ; 54) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6022069 ; 55) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6133658 ; 56) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6232003 ; 57) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6345513 ; 58) SCV30VAFHS, UDI-DI:10195594450007 (each) 50195594450005 (case), Lot Number: 6416679 ; 59) SNE11AN102, UDI-DI:10197106232293 (each) 50197106232291 (case), Lot Number: 6568688 ; 60) SNE11AN10E, UDI-DI:10197106067062 (each) 50197106067060 (case), Lot Number: 6560950 ;

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Feb 19, 2025
Recall initiation date: Nov 8, 2024
Center classification date: Feb 10, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records