Z-3293-2026 Class II Ongoing
FDA device recall Z-3293-2026 was initiated by American Contract Systems Inc on Aug 10, 2026 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 1,804 kits total.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 7, 2026
- Initiation Date
- Aug 10, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,804 kits total
Product Description
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
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).
Distribution Pattern
US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and South Dakota.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3293-2026
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026