FDAFDA recall Z-3298-2026 · Oct 7, 2026
Cardinal Health 200, LLC: Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT recall
Recall found
Product
Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH , Catalog Number: PB63VHSTC
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 1) PB63VHSTC, UDI-DI: 10197106980866(each), 50197106980864(case), Lot Number: 25069FG2 ; 2) PB63VHSTC, UDI-DI: 10197106980866(each), 50197106980864(case), Lot Number: 25101FG2
- Quantity
- 22 kits
- Distribution
- US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX.
- Recalling firm
- Cardinal Health 200, LLC, Waukegan, IL
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-18
Source: openFDA enforcement record Z-3298-2026 · search recall number Z-3298-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.