Device recall
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
- Recall number
- Z-3294-2026
- Event id
- 99759
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- American Contract Systems Inc
- Report date
- Oct 7, 2026
- Posted
- Sep 25, 2026
- Initiated
- Aug 10, 2026
- Center classification date
- Sep 25, 2026
- Product code
- OJF
- Device type
- Hysterectomy Kit
- Reason
- 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).
- Root cause
- Under Investigation by firm
- Quantity
- 1,804 kits total
- Code info
- 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
- Distribution
- US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and South Dakota.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Tiffin, OH, United States