- Recalling firm
- Cardinal Health 200, LLC
- 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.
- Affected products (lot / model / serial)
- 1) PB63VHSTC, UDI-DI: 10197106980866(each), 50197106980864(case), Lot Number: 25069FG2 ; 2) PB63VHSTC, UDI-DI: 10197106980866(each), 50197106980864(case), Lot Number: 25101FG2
- Units affected
- 22 kits
- Distribution pattern
- US Nationwide distribution in the states of CA, IL, KY, MO, NC, NY, OH, TX.
- Firm location
- Waukegan, IL, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3298-2026
- Recall initiated
- August 18, 2026
- FDA classification date
- September 25, 2026
- FDA report date
- October 7, 2026
- FDA event ID
- 99768
- Last updated on HTM Vibe
- October 13, 2026
