Home › Atos Medical AB › Provox StabiliBase (15 pcs)
Provox StabiliBase (15 pcs)
Atos Medical AB · Model 7289 · UDI-DI 07331791008016
10
510(k) clearances
5,063
Adverse events (16 deaths)
48
Recalls
986
Facilities
Description
Provox StabiliBase adhesive is a single use device intended for laryngectomized patients breathing through a tracheostoma. The device is attached to the skin around the tracheostoma in order to provide attachment for components of the Provox HME System. The design of the StabiliBase adapter can be especially suitable for deep tracheostomas.
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.