Device recall
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays CARDIAC HEART BUNDLE NS Model No. LMCH99P OPEN HEART 2 RCH¿ 0248495 Model No. RCOH62C
- Recall number
- Z-3293-2026
- 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
- OEZ
- Device type
- Cardiovascular Procedure 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
- 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
- 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