Teleflex Medical Recalls Hudson RCI Adult Universal Ventilator Circuits
Teleflex Medical is recalling 2,600 Hudson RCI Adult Universal Ventilator Circuits because the inspiratory and expiratory tubes are transposed.
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 functional defect (transposed tubes) 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 where injury has not yet been reported.
Plain-English summary
Teleflex Medical is recalling 2,600 units of the Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit with Column. The recall is due to complaints that the inspiratory and expiratory tubes are transposed.
The affected products are identified by Lot Numbers 02K1300128 and 02L1302324. These units were distributed in the United States to the states of AL, AZ, CA, GA, IL, KY, LA, MA, MI, MN, NJ, NY, NC, OH, OK, OR, PA, TN, TX, and WA.
Healthcare facilities should stop using the affected ventilator circuits and contact Teleflex Medical for instructions on how to return or replace the products.
The recalled product
- Product
- Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit with Column
- Manufacturer
- Teleflex Medical
- Affected units
- 2,600
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 (1)
- Lot Numbers : 02K1300128 and 02L1302324
Distribution
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