Z-3100-2026 Class II Ongoing
FDA device recall Z-3100-2026 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: 61 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
- 61 units
Product Description
Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ENT HARVEST , Catalog Number: PEVMETBJX; 2) KIT, ENT HARVEST , Catalog Number: PEVMETB37
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) PEVMETBJX, UDI-DI: 10198956176041(each), 50198956176049(case), Lot Number: NGKT2394 ; 2) PEVMETBJX, UDI-DI: 10198956176041(each), 50198956176049(case), Lot Number: NGKT2394 ; 3) PEVMETB37, UDI-DI: 10198956212039(each), 50198956212037(case), Lot Number: NGKT2394