FDAFDA recall Z-3294-2026 · Oct 7, 2026
American Contract Systems Inc: Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Cathete recall
Recall found
Product
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
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).
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 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
- Quantity
- 1,804 kits total
- Distribution
- US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and South Dakota.
- Recalling firm
- American Contract Systems Inc, Tiffin, OH
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-10
Source: openFDA enforcement record Z-3294-2026 · search recall number Z-3294-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.