- 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)
- LMCH99P UDI-DI 191072228147 Lots 42-8533511 42-8669111 42-8763811 42-8811311 42-8825411 42-8869411 RCOH62C UDI-DI 191072230942 Lots 42-8504411 42-8561511 42-8668211 42-8737811 42-8797911 42-8862511
- 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-3293-2026
- 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
