Teleflex Recalls Hudson RCI Breathing Circuits Due to Temperature Probe Defect
Teleflex Medical is recalling Hudson RCI breathing circuits because the temperature probe does not properly connect to the temperature port.
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 defect that could compromise the function of a ventilator circuit, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Teleflex Medical is recalling Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), Rx Only, Single Patient Use. The product is intended as a conduit for respiratory gas between a patient and a ventilator and includes heated wires for use with a Concha Column Humidifier.
The recall is being conducted because the temperature probe does not properly connect to the temperature port. The affected units are catalog number 1696 with specific lot numbers listed in the agency documentation. A total of 11,679 units were distributed worldwide, including in the United States and in Argentina, Chile, Colombia, and the Philippines.
Healthcare providers and facilities should stop using the affected breathing circuits and contact Teleflex Medical for further instructions on the recall.
The recalled product
- Product
- Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), Rx Only, Single Patient Use. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a…
- Manufacturer
- Teleflex Medical
- Affected units
- 11,679
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 (12)
- Catalog Number: 1696
- Lot numbers: 02K1301986
- 02L1300010
- 02L1300037
- 02L1301081
- 02L1301783
- 02M1300190
- 02M1300236
- 02A1400518 02A1401286
- 02A1402358
- 02B1400178
- 02B1400715 & 02B1401320.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Teleflex Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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