Condenser, Heat And Moisture (artificial Nose)
Anesthesiology · 21 CFR 868.5375
Recent MDR events
435 adverse event reports on file
- HV TRACHJul 28, 2026MalfunctionTeleflex Medical Sdn. Bhd.8040412-2026-00115
- HV TRACHJul 28, 2026MalfunctionTeleflex Medical Sdn. Bhd.8040412-2026-00114
- AIRLIFEApr 24, 2026InjuryAirlife1314417-2026-00026
- DARApr 23, 2026MalfunctionCovidien9680661-2026-00034
- DARApr 23, 2026MalfunctionCovidien9680661-2026-00035
- DARApr 23, 2026MalfunctionCovidien9680661-2026-00036
- HV TRACHApr 20, 2026MalfunctionTeleflex Medical Sdn. Bhd.8040412-2026-00046
- HV TRACHApr 20, 2026MalfunctionTeleflex Medical Sdn. Bhd.8040412-2026-00048
- H-V MICRO+ 3.5 STERILApr 20, 2026MalfunctionTeleflex Medical Sdn. Bhd.8040412-2026-00049
- TRACH-VENT+CLEANApr 17, 2026MalfunctionTeleflex Medical Sdn. Bhd.8040412-2026-00054
Event type breakdown
Recalls
15 recall events for this product code
- Smiths Medical ASD Inc.Open, ClassifiedOct 23, 2024
smiths medical portex, Y' PIECE 15MM, REF 100/276/000
Uncertainty in the seal integrity of the sterile packaging.
Z-0145-2025 · View FDA record ↗ - Smiths Medical ASD Inc.Open, ClassifiedOct 23, 2024
smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
Uncertainty in the seal integrity of the sterile packaging.
Z-0146-2025 · View FDA record ↗ - Smiths Medical ASD Inc.Open, ClassifiedOct 23, 2024
smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS
Uncertainty in the seal integrity of the sterile packaging.
Z-0147-2025 · View FDA record ↗ - Teleflex MedicalTerminatedAug 29, 2016
MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.
Cracking may occur at the 15mm and 22mm ISO female connector.
Z-2683-2016 · View FDA record ↗ - Teleflex MedicalTerminatedAug 9, 2016
Servo Humidifier 163, Model 01-06-8125-8, REF 6419365
Cracks may occur at the 15mm and 22mm ISO female connector.
Z-2374-2016 · View FDA record ↗ - Arc Medical IncTerminatedMay 9, 2015
ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17.
Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.
Z-1596-2015 · View FDA record ↗ - Teleflex, Inc.TerminatedFeb 6, 2015
MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8.
Connector mount cracks which may lead to a leak failure during use and necessitate immediate replacement in the breathing circuit. If leak exists and is left untreated, patient may be deprived of adequate anesthetic gases over a period of time and serious adverse health consequences may occur.
Z-1008-2015 · View FDA record ↗ - Teleflex MedicalTerminatedFeb 6, 2015
MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Model No. 01-06-8125-8.
Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female connector.
Z-1051-2015 · View FDA record ↗ - Vital Signs Devices, a GE Healthcare CompanyTerminatedJul 30, 2011
Vital Signs- A GE Healthcare Company - Hygroscopic Condenser Humidifier (HCH)/Anesthesia Breathing Circuit; GE Medical Systems SCS 283 rue de la Miniere 78530 B
The Hygroscopic Condenser Humidifier (HCH) device may have an occlusion that can prevent proper flow of the medical gases or oxygen, possibly resulting in insufficient oxygen delivered to the patient.
Z-2848-2011 · View FDA record ↗ - Smiths Medical ASD, Inc.TerminatedJul 22, 2004
Portex Thermovent T, Heat and Moisture Exchangers
Sterility of the device is compromised due to lack of package integrity
Z-1129-04 · View FDA record ↗
Registered firms
150 firms currently registered for this product code
Passy-muir, Inc.
IRVINE, CA, US
Vr Medical Technology Co., Ltd.
KUNSHAN Jiangsu, CN
Sunmed Ap, Ltd., Warehouse No. 2
ZHUHAI Guangdong, CN
Teleflex Medical Sdn. Bhd.
KAMUNTING Perak, MY
Biopsybell S.r.l.
MIRANDOLA Modena, IT
Midwest Sterilization Corp.
JACKSON, MO, US
Saint Jones Management Lp Eood
Sofia Sofia-Grad, BG
Sterigenics Us Llc
West Memphis, AR, US
Medease Life Co.,ltd
DANYANG Jiangsu, CN
Dujo Logos Inc. Dba: Medicomp Medical
Princeton, MN, US
Yasco Enterprise Corp.
Chiayi County, TW
Hsiner Co., Ltd.
Taichung City, TW
Shaoxing Undis Medical Technology Company Limited
Shaoxing Zhejiang, CN
Besmed Health Business Corporation
New Taipei City, TW
Ningbo Ningyuan Import & Export Co., Ltd.
NINGBO, ZHEJIANG, CN
Worldwide Supplies Limited
Hong Kong, HK
Teleflex Medical Llc
Morrisville, NC, US
Draegerwerk Ag & Co. Kgaa
LUEBECK Schleswig-Holstein, DE
Ups Supply Chain Solutions, Inc.
Louisville, KY, US
Intechrity Inc
Irvine, CA, US
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
Avanos Medical, Inc.
Alpharetta, GA, US
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Flexicare Medical Ltd.
RHONDDA CYNON TAFF Wales, GB
Uab Intersurgical
PABRADE Svencionys, LT
510(k) clearances
73 clearances for this product code
- Intertech Resources, Inc.Jan 30, 1996
K955008 · HEAT & MOISTURE EXCHANGER
- Engstrom MedicalOct 20, 1995
K954194 · DISPOSABLE HME/FILTER
- Intertech Resources, Inc.Sep 15, 1995
K953580 · HEAT MOISTURE EXCHANGER
- Icor ABSep 7, 1995
K953507 · TYPE 1 & 2 (HUMIDAIR I & II)
- Gibeck, Inc.Aug 25, 1995
K953544 · HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT
- Gibeck, Inc.Aug 25, 1995
K953491 · HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE
- Hospitak, Inc.Aug 25, 1995
K953620 · WARM N WET HMEF W/LUER ADAPTER
- Edentec Corp.Aug 25, 1995
K953540 · EEE