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Condenser, Heat And Moisture (Artificial Nose)
FDA product code BYD · Class 1 · Anesthesiology
683
Registered devices
446
Adverse events
15
Recalls
73
510(k) clearances
Devices with this code
HUDSON RCI — TELEFLEX INCORPORATEDProvox Life Coming Home USA — Atos Medical ABGIBECK — TELEFLEX INCORPORATEDAirLife™ — AIRLIFEResp-O2 Heat Moisture Exchanger (HME) 1500 Tracheostomy — Dynarex CorporationPortex — ICU MEDICAL, INC.InHealth Technologies; Blom-Singer — Freudenberg Medical, LLCHME without Gas Sampling Port; Angled — MedicompPortex — ICU MEDICAL, INC.Provox Life Energy HME Experience — Atos Medical ABGIBECK — TELEFLEX INCORPORATEDRespVent™ — CUTTING EDGE HC BRANDS LLCPortex — ICU MEDICAL, INC.Pharma Neo Basic — Pharma Systems Ps ABAirLife™ — AIRLIFEPharma Trach Multi Function — Pharma Systems Ps ABHME — PEPPER MEDICAL INC.Provox Life Day & Night Experience Oval — Atos Medical ABAirLife™ Hygroscopic Condenser Humidifier — AIRLIFETRACOE® modular — Tracoe medical GmbHHME HumidStar 55 — Drägerwerk AG & Co. KGaAPortex — ICU MEDICAL, INC.Climavent S HME Small — FLEXICARE MEDICAL LIMITEDPortex — ICU MEDICAL, INC.
Recent 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 ven |
| 2015-12-03 | Teleflex Medical | Cracks may occur at the 15mm and 22mm ISO female connector. |
| 2015-12-03 | Teleflex Medical | Cracking 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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