Z-3294-2026 Class II Ongoing
FDA device recall Z-3294-2026 was initiated by American Contract Systems Inc on Aug 10, 2026 and is designated Class II. Reason for recall: Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated… The recall status is ongoing. Affected quantity: 1,804 kits total.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 7, 2026
- Initiation Date
- Aug 10, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,804 kits total
Product Description
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ABDOMINAL HYSTERECTOMY - 205989 Model No. MHAH55AM LAVH-LAP COLON Model No. SPLL54U VAG HYST PACK Model No. SPVH62P
Reason for Recall
Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. Use of a contaminated wipe may lead to localized skin effects such as irritation, erythema, or mild inflammation. Failure to perform pericare due to disposal of contaminated wipes may increase risk of localized infection or catheter-associated urinary tract infection (CAUTI).
Distribution Pattern
US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and South Dakota.
Code Information
MHAH55AM UDI-DI 191072236487 Lots 42-8529911 42-8649211 42-8687711 42-8797811 42-8857011 42-8869711 SPLL54U UDI-DI 191072239181 Lots 07-2516111 07-2528611 07-2545611 07-2547911 07-2561411 SPVH62P UDI-DI 191072238771 Lots 07-2544611 12-7436711
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3294-2026
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026