← FDA ENFORCEMENT
Z-3296-2026Class II

Cardinal Health 200, LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Cardinal Health 200, LLC
Product type
Device
Status
Ongoing
Report date
2026-10-07
Distribution
US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX.
Firm state
IL
Product quantity
344 kits
Initiated by
Voluntary: Firm initiated
Reason for recall

The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall.

Product description

Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,GU DAVINCI , Catalog Number: PGVMDVBWU; 2) KIT,GU DAVINCI , Catalog Number: PGVMDVBWV; 3) KIT,GU DAVINCI , Catalog Number: PGVMDVB26; 4) KIT,GU DAVINCI , Catalog Number: PGVMDVB27; 5) KIT,GU DAVINCI , Catalog Number: PGVMDVB28; 6) KIT,GU DAVINCI , Catalog Number: PGVMDVB29; 7) COLORECTAL PACK , Catalog Number: SBA73CLKFD; 8) COLORECTAL PACK , Catalog Number: SBA73CLK26

Code / lot info

1) PGVMDVBWU, UDI-DI: 10888439626186(each), 50888439626184(case), Lot Number: 24317FG2 ; 2) PGVMDVBWU, UDI-DI: 10888439626186(each), 50888439626184(case), Lot Number: 24353FG2 ; 3) PGVMDVBWU, UDI-DI: 10888439626186(each), 50888439626184(case), Lot Number: 24317FG2 ; 4) PGVMDVBWU, UDI-DI: 10888439626186(each), 50888439626184(case), Lot Number: 25069FG2 ; 5) PGVMDVBWU, UDI-DI: 10888439626186(each), 50888439626184(case), Lot Number: 25045FG2 ; 6) PGVMDVBWU, UDI-DI: 10888439626186(each), 50888439626184(case), Lot Number: 25069FG2 ; 7) PGVMDVBWV, UDI-DI: 10198956204034(each), 50198956204032(case), Lot Number: 24353FG2 ; 8) PGVMDVBWV, UDI-DI: 10198956204034(each), 50198956204032(case), Lot Number: 25101FG2 ; 9) PGVMDVBWV, UDI-DI: 10198956204034(each), 50198956204032(case), Lot Number: 25148FG2 ; 10) PGVMDVBWV, UDI-DI: 10198956204034(each), 50198956204032(case), Lot Number: 25217FG2 ; 11) PGVMDVB26, UDI-DI: 10198956007796(each), 50198956007794(case), Lot Number: 24309FG2 ; 12) PGVMDVB27, UDI-DI: 10198956054714(each), 50198956054712(case), Lot Number: 24325FG2 ; 13) PGVMDVB28, UDI-DI: 10198956079847(each), 50198956079845(case), Lot Number: 24317FG2 ; 14) PGVMDVB28, UDI-DI: 10198956079847(each), 50198956079845(case), Lot Number: 24325FG2 ; 15) PGVMDVB29, UDI-DI: 10198956094024(each), 50198956094022(case), Lot Number: 24317FG2 ; 16) PGVMDVB29, UDI-DI: 10198956094024(each), 50198956094022(case), Lot Number: 24348FG2 ; 17) SBA73CLKFD, UDI-DI: 10197106633960(each), 50197106633968(case), Lot Number: 25055FG2 ; 18) SBA73CLK26, UDI-DI: 10198956029828(each), 50198956029826(case), Lot Number: 24309FG2

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →