- 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)
- UDI-DI 191072236531 Lots 42-8513411 42-8580011 42-8663211 42-8775711 42-8801311 42-8840611 42-8865911
- 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-3292-2026
- 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
