Z-3292-2026

Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC...

Name: Z-3292-2026 Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC...
Creator: American Contract Systems Inc
Published: 2026-08-10
License: https://open.fda.gov/license/

American Contract Systems Inc / initiated 2026-08-10 / Open, Classified

FDA source

Recall record

Recall number: Z-3292-2026
Status: Open, Classified
Initiated: 2026-08-10
Posted: 2026-09-25
Recalling firm: American Contract Systems Inc
Product: Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays ROBOTIC PACK - 242561 Model No. MHRB88AO
Product code: FDE Laparoscopy Kit
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).
FDA 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 patients with urinary catheters.
Quantity in commerce: 1,804 kits total
Distribution: US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and South Dakota.
Product codes and lots: UDI-DI 191072236531 Lots 42-8513411 42-8580011 42-8663211 42-8775711 42-8801311 42-8840611 42-8865911

Product code FDE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-10-02. View this recall on fda.gov (opens on fda.gov)