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Areza Medical
ADVANCED MEDICAL ASSOCIATES, LLC · Model FT2X101 · UDI-DI 00850021481063
10
510(k) clearances
5,063
Adverse events (16 deaths)
48
Recalls
983
Facilities
Description
Areza Fabripore: Soft Fabric Porous Adhesive Skin Tape 2" x 10' (1 Roll) is composed of a soft, porous, semi-occlusive fabric backing covered with an adhesive layer. This Fabripore adhesive tape is designed to decrease the risk of maceration while securing other dressings (primary) over wounds, catheters, tubings, electrodes, and any other device items that may need fixation. Conveniently perforated every 2 inches to be able to tear it by hand for easier handling. No latex is used in production.
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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Get your free API keyRead the docsData 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.