Device recall
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH , Catalog Number: PB63VHSTC
- Recall number
- Z-3298-2026
- Event id
- 99768
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Cardinal Health 200, LLC
- Report date
- Oct 7, 2026
- Posted
- Sep 25, 2026
- Initiated
- Aug 18, 2026
- Center classification date
- Sep 25, 2026
- Product code
- OJF
- Device type
- Hysterectomy Kit
- 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.
- Root cause
- Under Investigation by firm
- Quantity
- 22 kits
- Code info
- 1) PB63VHSTC, UDI-DI: 10197106980866(each), 50197106980864(case), Lot Number: 25069FG2 ; 2) PB63VHSTC, UDI-DI: 10197106980866(each), 50197106980864(case), Lot Number: 25101FG2
- Distribution
- US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Waukegan, IL, United States