Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
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 it was recalled
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
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 ;
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
Recall record
- Recalling firm
- Cardinal Health 200, LLC
- Product type
- Devices
- Recall number
- Z-1129-2025
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Waukegan, IL
- Recall initiated
- 2024-11-08
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-1129-2025 · Source: openFDA enforcement.