Teleflex Servo Humidifier 163 Recalled Due to Connector Cracks
Teleflex Medical is recalling Servo Humidifier 163 units because cracks may occur at the ISO female connectors.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a structural defect (cracks) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Teleflex Medical is recalling 2,700 units of the Servo Humidifier 163, Model 01-06-8125-8, REF 6419365. The recall involves specific lots (201450, 201451, 201452, 201504) that were distributed nationwide in the United States, specifically in the states of Florida, Kansas, and West Virginia.
The recall is being issued because cracks may occur at the 15mm and 22mm ISO female connector. This 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 the patient.
Healthcare facilities and consumers should stop using the affected devices and contact Teleflex Medical for instructions on replacement or return.
The recalled product
- Product
- Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical 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 trachea) to…
- Manufacturer
- Teleflex Medical
- Category
- Medical Device — Respiratory
- Affected units
- 2,700
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 (4)
- Lots 201450
- 201451
- 201452
- 201504
Distribution
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