🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: November 8, 2024 Cardinal Health 200 Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    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 ;
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Cardinal Health 200, LLC
Reason for Recall:
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

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) 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 ;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1129-2025

Related Recalls

Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370 Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 5. 8888571299 Cardinal Health Aqua-Seal CDU, Wet Suction 6. 8888571406 Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 7. 8888571315 Cardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 8. 8884713100 Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 9. 1814713105 OUS¿Only - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 10. 1180571570 OUS¿Only - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 11. 8884713308 Cardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 12. 8884713900 Cardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL

Cardinal Health 200

Class I - Dangerous

The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.

Dec 26, 2025 Other Medical Devices Nationwide View Details →

ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile; CT5503T ChemoPlus Full Coverage Gown, Closed Back, Large, Medium Blue, Non-sterile; CT5504T ChemoPlus Full Coverage Gown, Closed Back, Extra Large, Medium Blue, Non-sterile; CT5505T ChemoPlus Full Coverage Gown, Closed Back, Extra Extra Large, Medium Blue, Non-sterile; DP5001GT ChemoPlus Full Coverage Gown, Open Back, Large, medium Blue, Non- sterile; DP5002GT ChemoPlus Full Coverage Gown, Open Back, Extra Large, medium Blue, Non-sterile; DP5003GT ChemoPlus Full Coverage Gown, Open Back, Medium, medium Blue, Non-sterile; DP5004GT ChemoPlus Full Coverage Gown, Open Back, Extra Extra Large, medium Blue, Non-sterile; CT5500TS ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Sterile; CT5502TS ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile; CT5503TS ChemoPlus Full Coverage Gown, Closed Back, Large, Medium Blue, Sterile; CT5504TS ChemoPlus Full Coverage Gown, Closed Back, Extra Large, Medium Blue, Sterile; CT5505TS ChemoPlus Full Coverage Gown, Closed Back, Extra Extra Large, Medium Blue, Sterile;

Cardinal Health 200

Class I - Dangerous

Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.

Nov 12, 2025 Infusion Pumps Nationwide View Details →