# Class II recall Z-3294-2026: American Contract Systems Inc

**Predicate Speed & CAPA Advisory Opportunity Score:** 62/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3294-2026 |
| Recalling firm | American Contract Systems Inc |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| 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 | 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). |
| Quantity | 1,804 kits total |
| Distribution | US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and South Dakota. |
| Recall initiated | 2026-08-10 |
| Reported | 2026-10-07 |
| Firm location | Tiffin, OH, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 29 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3294-2026%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.