Recall Z-3097-2026
- Recall number
- Z-3097-2026
- Event number
- 99553
- Firm
- Cardinal Health 200, LLC
- Firm FEI
- 3001236905
- Product code
- NWU
- Status
- Open, Classified
- Initiated
- 2026-07-29
- Posted
- 2026-09-03
- Root cause
- Process change control
- 510(k) numbers
- K874045, K933268, K813332
Product#
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,ROBOTICS DH , Catalog Number: PGOCRDNHD; 2) KIT, EAS ROBOTIC , Catalog Number: PG36RPEAB; 3) KIT, VIDEO THORACOSCOPY CMC , Catalog Number: PVCGVTACF
Reason for Recall#
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation.