Teleflex Recalls MAQUET SERVO Humidifiers Due to Cracked Flex Tubes
Teleflex Medical is recalling MAQUET SERVO Humidifier 163 units because cracks may occur in the corrugated flex tube, posing a risk to patients.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source metadata explicitly identifies the agency classification as Class I. Per the rubric, FDA Class I recalls are assigned a severity score of 5 (Critical).
Plain-English summary
Teleflex Medical is recalling 100 units of the MAQUET, SERVO Humidifier 163 (Catalog No: XKC01-06-8125-8, Model No. 01-06-8125-8). 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 were distributed to Florida, Kansas, Michigan, and West Virginia.
The recall is due to defects in the 15 mm and 22 mm ISO female connector, where cracks may occur in the center of the corrugated flex tube. The specific lot numbers involved are 201413, 201414, 201415, 201417, 201419, and 201422.
Healthcare providers and patients should stop using the affected devices and contact Teleflex Medical for instructions on replacement or return. This recall is classified as Class I by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.
The recalled product
- Product
- MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Model No. 01-06-8125-8. 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…
- Manufacturer
- Teleflex Medical
- Affected units
- 100
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 (5)
- Lot numbers: 201413
- 201414
- 201415
- 201417
- 201419 and 201422.
Distribution
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