Recall Z-3292-2026 ยท FDE Laparoscopy Kit
American Contract Systems Inc
Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 242561 Model No. MHRB88AO
| Date | Sep 25, 2026 (initiated Aug 10, 2026) |
| Status | Open, Classified |
| 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 |
| Action | Firm began notifying affected distributors via email on August 10, 2026. Distributors were instructed to notify end-users. Customers were instructed to identify, segregate, and quarantine all impacted products. Customers are to add recall labels to affected kits to ensure the impacted component is discarded prior to use. An amended customer letter was sent out on August 28, 2026, which added the following instruction: Users should source alternative cleansing wipes for the impacted product lots and ensure they continue to follow their facility protocols for providing perineal care for patie |
| Quantity | 1,804 kits total |
| Distribution | US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and South Dakota. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.