TemporaryFDAOngoing
Can cause harm that is usually temporary.
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH , Catalog Number: PB63VHSTC
Check the device or its packaging for
1) PB63VHSTC, UDI-DI: 10197106980866(each), 50197106980864(case), Lot Number: 25069FG2 ; 2) PB63VHSTC, UDI-DI: 10197106980866(each), 50197106980864(case), Lot Number: 25101FG2
- Why
- 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.
- Distributed
- US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX.
- Company
- Cardinal Health 200, LLC
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-3298-2026 · retrieved 25 September 2026
Read the official notice