- Recalling firm
- American Contract Systems Inc
- 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).
- Affected products (lot / model / serial)
- 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
- Units affected
- 1,804 kits total
- Distribution pattern
- US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and South Dakota.
- Firm location
- Tiffin, OH, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3294-2026
- Recall initiated
- August 10, 2026
- FDA classification date
- September 25, 2026
- FDA report date
- October 7, 2026
- FDA event ID
- 99759
- Last updated on HTM Vibe
- October 13, 2026
