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Provox Luna Set
Atos Medical AB · Model 8025 · UDI-DI 07331791010699
10
510(k) clearances
435
Adverse events (11 deaths)
15
Recalls
125
Facilities
Description
The Provox Luna Set is a combination of Provox Luna HME and Provox Luna Adhesive. Provox Luna HME: The Provox Luna HME is a single use heat- and moisture exchanger, attachable to the Provox Luna Adhesive, for night-time use after total laryngectomy. Provox Luna Adhesive: The Provox Luna Adhesive is a skin friendly, single use adhesive that provides attachment for the Provox Luna HME for night time use after total laryngectomy.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-07-18 | Smiths Medical ASD Inc. | Uncertainty in the seal integrity of the sterile packaging. |
| 2024-07-18 | Smiths Medical ASD Inc. | Uncertainty in the seal integrity of the sterile packaging. |
| 2024-07-18 | Smiths Medical ASD Inc. | Uncertainty in the seal integrity of the sterile packaging. |
| 2022-04-11 | TELEFLEX MEDICAL INC | Reports received of torn corrugated breathing tubes. |
| 2021-03-29 | Atos Medical AB | Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma. |
| 2020-09-04 | AB ULAX | Firm has received 6 complaints that the Heat Moisture Exchanger (HME) disconnected from the closed respiratory circuit during use. If the HME separates, the ventilator circuit may |
| 2015-12-03 | Teleflex Medical | Cracking may occur at the 15mm and 22mm ISO female connector. |
| 2015-12-03 | Teleflex Medical | Cracks may occur at the 15mm and 22mm ISO female connector. |
| 2015-02-19 | Arc Medical Inc | Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly. |
| 2015-01-12 | Teleflex Medical | Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female connector. |
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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.