Z-3096-2026 Class II Ongoing
FDA device recall Z-3096-2026 was initiated by Cardinal Health 200, LLC on July 29, 2026 and is designated Class II. 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, … The recall status is ongoing. Affected quantity: 19 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 9, 2026
- Initiation Date
- July 29, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19 units
Product Description
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, LUNG TX CIRCULATOR , Catalog Number: OVC3507231
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.
Distribution Pattern
US Nationwide distribution.
Code Information
1) OVC3507231, UDI-DI: 10198956232457(each), 50198956232455(case), Lot Number: NGKU0957