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Urofoam®-2 Double-Sided Adhesive Foam Strip Box of 50

UROCARE PRODUCTS, INC. · Model 5200 · UDI-DI 00792293052001

KGX NNX

510(k) clearances

4,983

Adverse events (15 deaths)

Recalls

983

Facilities

Description

Urofoam®-2 double-sided adhesive foam strips are soft, pliable foam strips specifically designed for the unique application of male external catheters to the body and are suitable for use with both standard and self-adhering type catheters. They provide a comfortable, effective way to secure a male external catheter to the body. They are easy to apply and remove so when it comes time to change that catheter, it can be changed easily and quickly. It is recommended that a male external catheter be changed once a day to promote healthy skin, however, with the use or Urofoam® strips, a male external catheter can be held in place for up to three days—results may vary, but it's nice to know that when you need to depend on an adhesive strip, you can depend on Urofoam®.

Recalls

Date	Firm	Reason
2025-12-26	GOLD STAR DISTRIBUTION INC	Potential exposure of rodents and rodent activity in the distribution center.
2025-11-25	Ferndale Laboratories, Inc.	Butyrate tube cracks during actuation, rendering product unusable.
2025-10-27	Medline Industries, LP	Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
2025-10-27	Medline Industries, LP	Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
2025-10-27	Medline Industries, LP	Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
2025-10-27	Medline Industries, LP	Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
2025-10-27	Medline Industries, LP	Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
2025-10-27	Medline Industries, LP	Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
2025-10-27	Medline Industries, LP	Medline has identified that all lots of the Curad Touch-Free and Quick-Strip Bandages may exhibit open seals in the packaging which may compromise the sterility of the product.
2024-04-17	Cardinal Health 200, LLC	Potential contamination of the product with latex adhesive residual.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.