Recall Z-3296-2026— Cardinal Health 200, LLC
Class II · Ongoing
Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2026-08-18. FDA's recall record names no specific 510(k) clearance for this event. Product: 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. Reason: 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..
- Recalling firm
- Cardinal Health 200, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-08-18
- Firm location
- Waukegan, IL, United States
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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.