Teleflex Recalls MAQUET Servo Humidifier 163 Due to Connector Cracks
Teleflex is recalling 18 MAQUET Servo Humidifier 163 units because connector mount cracks may cause leaks, potentially depriving patients of adequate anesthetic gases.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that serious adverse health consequences may occur if the leak is left untreated, which aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk scenarios warranting a Severe classification.
Plain-English summary
Teleflex, Inc. is recalling 18 units of the MAQUET Servo Humidifier 163 (Model No. 01-06-8125-8, catalog no. XKC01-06-8125-8). The device is a heat and moisture condenser intended to be positioned over a tracheotomy or tracheal tube to warm and humidify gases breathed in by a patient. The affected units are identified by batch numbers 201321, 201323, and 201324.
The recall is due to connector mount cracks which may lead to a leak failure during use. If a leak exists and is left untreated, the patient may be deprived of adequate anesthetic gases over a period of time, which may result in serious adverse health consequences. The devices were distributed in the states of Florida, Michigan, West Virginia, and Kansas.
Healthcare facilities and consumers should immediately stop using the affected devices and contact Teleflex, Inc. for instructions on replacement or return.
The recalled product
- Product
- MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the…
- Manufacturer
- Teleflex, Inc.
- Affected units
- 18
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Batch Numbers: 201321
- 201323
- and 201324.
Distribution
Related recalls
Same manufacturer · Teleflex, Inc.
See all →- HighTeleflex Recalls Tracheopart Sets Due to Connector Detachment
FDA (Devices) · 2015-08-26
- ModerateTeleflex Recalls Bronchial Double Lumen Tube Sets Due to Connector Detachment
FDA (Devices) · 2015-08-26
- HighTeleflex Recalls Bronchial One Lumen Tubes Due to Connector Detachment
FDA (Devices) · 2015-08-26
- ModerateTeleflex Recalls Bronchial Double Lumen Tube Sets Due to Connector Detachment
FDA (Devices) · 2015-08-26
- HighTeleflex Recalls Bronchial Double Lumen Tube Sets Due to Connector Detachment
FDA (Devices) · 2015-08-26
Same hazard · leak failure
See all →- HighMED-EL Mi1000 Cochlear Implant Recall Due to Helium Leak Test Failures
FDA (Devices) · 2019-08-14
Similar recalls
- CriticalTeleflex Recalls MAQUET SERVO Humidifiers Due to Cracked Flex Tubes
FDA (Devices) · 2015-02-18
- HighTeleflex Servo Humidifier 163 Recalled Due to Connector Cracks
FDA (Devices) · 2016-08-17
- HighTeleflex Recalls MAQUET Servo Humidifier 163 Units Due to Connector Cracking
FDA (Devices) · 2016-09-07
- CriticalTeleflex Medical Recalls Hudson RCI Comfort Flo Humidification Systems
FDA (Devices) · 2020-02-19
- SevereTeleflex Medical Recalls Hudson RCI Comfort Flo Humidifier Nebulizer Kits
FDA (Devices) · 2020-02-19
- SevereTeleflex Recalls ISIS HVT Tracheal Tubes Due to Kinking Risk
FDA (Devices) · 2014-03-05