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
FDA Recall Z-3293-2026 · Posted 2026-09-25
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Recalling FirmAmerican Contract Systems Inc
Recall StatusOpen, Classified
Product CodeOEZ
Date Initiated2026-08-10
Product Quantity1,804 kits total
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).
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.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the states of Iowa, Minnesota, Wisconsin, and South Dakota.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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