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Provox Life Sensitive Adhesive Round
Atos Medical AB · Model 7463 · UDI-DI 07331791014451
10
510(k) clearances
4,983
Adverse events (15 deaths)
48
Recalls
983
Facilities
Description
Provox Life Adhesives are single use adhesives that provide attachment for Provox Life HMEs and accessories after total laryngectomy. Provox Life Sensitive Adhesives have an adhesive material with permanent skin contact that is hypoallergenic and suitable for sensitive skin.
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.