Cardinal Health 200, LLC recalls Cardinal Health Presource Kits: 1) KIT
Reason for recall
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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
Lot / code information
- UDI
- 10197106291412 (each) 50197106291410 (case)
- Lot #
- 6788690 ; 2) PVV20110B
- UDI
- 10197106291412 (each) 50197106291410 (case)
- Lot #
- 6806122 ; 3) PVV20110B
- UDI
- 10197106291412 (each) 50197106291410 (case)
- Lot #
- 7160517 ; 4) PVV20110D
- UDI
- 10197106546505 (each) 50197106546503 (case)
- Lot #
- 7287574 ; 5) PVV2CA103
- UDI
- 10888439714081 (each) 50888439714089 (case)
- Lot #
- J46C12 ; 6) PVV2CA10T
- UDI
- 10888439349467 (each) 50888439349465 (case)
- Lot #
- J46C11 ; 7) PVV2CA10T
- UDI
- 10888439349467 (each) 50888439349465 (case)
- Lot #
- J43W16 ; 8) PVV2CA10T
- UDI
- 10888439349467 (each) 50888439349465 (case)
- Lot #
- J6022K ; 9) PVV2CA10T
- UDI
- 10888439349467 (each) 50888439349465 (case)
- Lot #
- J7708R ; 10) PVV2CA10T
- UDI
- 10888439349467 (each) 50888439349465 (case)
- Lot #
- J79Z50 ; 11) PVV2CA10U
- UDI
- 10888439693607 (each) 50888439693605 (case)
- Lot #
- J8241D ; 12) PVV2CA10U
- UDI
- 10888439693607 (each) 50888439693605 (case)
- Lot #
- J84K11 ; 13) PVV2CA10X
- UDI
- 10888439967265 (each) 50888439967263 (case)
- Lot #
- J8998R ; 14) PVV2CA10Y
- UDI
- 10195594175795 (each) 50195594175793 (case)
- Lot #
- 5140389 ; 15) PVV2CA10Y
- UDI
- 10195594175795 (each) 50195594175793 (case)
- Lot #
- 5664115 ; 16) PVV2CA10Y
- UDI
- 10195594175795 (each) 50195594175793 (case)
- Lot #
- 5858468 ; 17) PVV2CA10Y
- UDI
- 10195594175795 (each) 50195594175793 (case)
- Lot #
- 5858469 ; 18) PVV2CA10Y
- UDI
- 10195594175795 (each) 50195594175793 (case)
- Lot #
- 6116189 ; 19) PVV2CA10Y
- UDI
- 10195594175795 (each) 50195594175793 (case)
- Lot #
- 6251075 ; 20) SCV13AASLA
- UDI
- 10197106514481 (each) 50197106514489 (case)
- Lot #
- 7055826 ; 21) SCV13AASLA
- UDI
- 10197106514481 (each) 50197106514489 (case)
- Lot #
- 7287469 ; 22) SCV13AASLA
- UDI
- 10197106514481 (each) 50197106514489 (case)
- Lot #
- 7331456 ; 23) SCV13AASLA
- UDI
- 10197106514481 (each) 50197106514489 (case)
- Lot #
- 7332825 ; 24) SCV30VAF10
- UDI
- 10197106231142 (each) 50197106231140 (case)
- Lot #
- 6702001 ; 25) SCV30VAFH4
- UDI
- 10195594091989 (each) 50195594091987 (case)
- Lot #
- J8045P ; 26) SCV30VAFH5
- UDI
- 10195594154073 (each) 50195594154071 (case)
- Lot #
- 5138326 ; 27) SCV30VAFH6
- UDI
- 10195594243616 (each) 50195594243614 (case)
- Lot #
- J9699Y ; 28) SCV30VAFH7
- UDI
- 10195594324940 (each) 50195594324948 (case)
- Lot #
- 5405620 ; 29) SCV30VAFH8
- UDI
- 10195594381400 (each) 50195594381408 (case)
- Lot #
- 5138335 ; 30) SCV30VAFH9
- UDI
- 10195594616182 (each) 50195594616180 (case)
- Lot #
- D212939 ; 31) SCV30VAFH9
- UDI
- 10195594616182 (each) 50195594616180 (case)
- Lot #
- 5775803 ; 32) SCV30VAFHP
- UDI
- 10888439248883 (each) 50888439248881 (case)
- Lot #
- J3986T ; 33) SCV30VAFHP
- UDI
- 10888439248883 (each) 50888439248881 (case)
- Lot #
- J4219R ; 34) SCV30VAFHP
- UDI
- 10888439248883 (each) 50888439248881 (case)
- Lot #
- J4877C ; 35) SCV30VAFHQ
- UDI
- 10888439785494 (each) 50888439785492 (case)
- Lot #
- J6278H ; 36) SCV30VAFHQ
- UDI
- 10888439785494 (each) 50888439785492 (case)
- Lot #
- J6786K ; 37) SCV30VAFHQ
- UDI
- 10888439785494 (each) 50888439785492 (case)
- Lot #
- J76N07 ; 38) SCV30VAFHR
- UDI
- 10888439928877 (each) 50888439928875 (case)
- Lot #
- J86N63 ; 39) SCV30VAFHR
- UDI
- 10888439928877 (each) 50888439928875 (case)
- Lot #
- J86N65 ; 40) SCV30VAFHR
- UDI
- 10888439928877 (each) 50888439928875 (case)
- Lot #
- J70X09 ; 41) SCV30VAFHR
- UDI
- 10888439928877 (each) 50888439928875 (case)
- Lot #
- J9424P ; 42) SCV30VAFHS
- UDI
- 10195594450007 (each) 50195594450005 (case)
- Lot #
- 7332861 ; 43) SCV30VAFHS
- UDI
- 10195594450007 (each) 50195594450005 (case)
- Lot #
- 6701998 ; 44) SCV30VAFHS
- UDI
- 10195594450007 (each) 50195594450005 (case)
- Lot #
- 6748352 ; 45) SCV30VAFHS
- UDI
- 10195594450007 (each) 50195594450005 (case)
- Lot #
- 6748352 ; 46) SCV30VAFHS
- UDI
- 10195594450007 (each) 50195594450005 (case)
- Lot #
- 6470289 ; 47) SCV30VAFHS
- UDI
- 10195594450007 (each) 50195594450005 (case)
- Lot #
- 6775068 ; 48) SCV30VAFHS
- UDI
- 10195594450007 (each) 50195594450005 (case)
- Lot #
- 6775065 ; 49) SCV30VAFHS
- UDI
- 10195594450007 (each) 50195594450005 (case)
- Lot #
- 7005466 ; 50) SCV30VAFHS
- UDI
- 10195594450007 (each) 50195594450005 (case)
- Lot #
- 7280092 ; 51) SCV30VAFHS
- UDI
- 10195594450007 (each) 50195594450005 (case)
- Lot #
- 7280093 ; 52) SCV30VAFHS
- UDI
- 10195594450007 (each) 50195594450005 (case)
- Lot #
- 7005463 ; 53) SCV30VAFHS
- UDI
- 10195594450007 (each) 50195594450005 (case)
- Lot #
- 7332855 ; 54) SCV30VAFHS
- UDI
- 10195594450007 (each) 50195594450005 (case)
- Lot #
- 6022069 ; 55) SCV30VAFHS
- UDI
- 10195594450007 (each) 50195594450005 (case)
- Lot #
- 6133658 ; 56) SCV30VAFHS
- UDI
- 10195594450007 (each) 50195594450005 (case)
- Lot #
- 6232003 ; 57) SCV30VAFHS
- UDI
- 10195594450007 (each) 50195594450005 (case)
- Lot #
- 6345513 ; 58) SCV30VAFHS
- UDI
- 10195594450007 (each) 50195594450005 (case)
- Lot #
- 6416679 ; 59) SNE11AN102
- UDI
- 10197106232293 (each) 50197106232291 (case)
- Lot #
- 6568688 ; 60) SNE11AN10E
- UDI
- 10197106067062 (each) 50197106067060 (case)
- Lot #
- 6560950
Show 110 more code fieldsShow fewer
What the firm is doing
An URGENT: MEDICAL DEVICE CORRECTION OVER LABEL notification letter dated 11/8/24 was sent to customers. If you locate affected product within your facility, please complete the following: 1. QUARANTINE affected kits & ALERT your clinicians of this action 2. AFFIX a WARNING LABEL to the front of each Presource kit so that it is clearly visible to clinicians, instructing them to remove and discard all CODMAN Patties & Strips included with the Presource product. 3. RETURN a copy of the enclosed Acknowledgment Form confirming your receipt of this action and the completion of labeling product via fax to 614.652.9648. Should you have any questions, require additional labels or desire special assistance relating to this recall, please feel free to contact Cardinal Health Quality Systems at 800.292.9332.
DistributionShow detailsHide
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1129-2025
- FDA device classification · OEZOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.1200The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Cardinal Health 200, LLCSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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