Teleflex Medical Recalls Hudson RCI Concha Therm Neptune Humidifiers
Teleflex Medical is recalling Hudson RCI Concha Therm Neptune Humidifiers because a speaker failure could prevent audio alarms from sounding, potentially delaying patient treatment.
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 is classified as FDA Class II. The hazard involves a potential delay in patient treatment due to a failed alarm, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Teleflex Medical is recalling Hudson RCI Concha Therm Neptune Humidifiers, prescription-only devices intended to add moisture and sometimes warm breathing gases for patients. The recall involves 14,794 units with catalog numbers 425-00, 425-10, and 425-30.
The recall was initiated due to a speaker failure. If the speaker fails, the device will not sound an audio alarm when an event occurs, which could cause a potential delay in patient treatment.
The affected units were distributed nationwide in the U.S. and internationally in Argentina, Australia, Brazil, Canada, Chile, China, Europe, India, Japan, Mexico, South Korea, Taiwan, and the UK. Healthcare facilities should stop using the affected devices and contact Teleflex Medical for instructions on replacement or repair.
The recalled product
- Product
- Hudson RCI Concha Therm Neptune Humidifier, Rx Only, Product Usage: Usage: Device that is intended to add moisture to, and sometime to warm, the breathing gases for administration to a patient.
- Manufacturer
- Teleflex Medical
- Affected units
- 14,794
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 (2)
- Catalog #425-00
- 425-10 and 425-30.
Distribution
Distributed nationwide across the United States.
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