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OSSEOUS- TouchFree HME Series - Standard
EON MEDITECH PRIVATE LIMITED · Model EA910011 · UDI-DI 08904428745067
BYD
Prescription
10
510(k) clearances
440
Adverse events (11 deaths)
15
Recalls
125
Facilities
Description
The HMEs traps heat and moisture from exhaled air and makes inhaled air more humid and warmer to reduce mucus generation and irritation in wind pipe to make patient comfortable. It is artificial nose for laryngectomy patient. It comes in different level of humidification, breathing Resistance and filtration that makes to use in different situations.
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 | 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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