Teleflex Medical One Way Valve Recall for Potential Disconnection
Teleflex Medical is recalling specific lots of HUDSON RCI One Way Valves because they may disconnect, causing an interruption of ventilation to patients.
What this means for you
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 where a defect (disconnection) poses a risk of harm (interruption of ventilation) 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 Europe Ltd is recalling specific lots of the MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port (REF 1644). The recall involves 103,910 units that were distributed in the United States, Australia, and New Zealand. The affected lot numbers are listed in the source metadata.
The recall is being issued because the one-way valves may disconnect at the joint between the two components that make up the device. This disconnection would cause an interruption of ventilation to the patient. The product is used in respiratory and anesthesia circuits to connect two or more components of a breathing system.
Healthcare facilities and consumers should stop using the affected valves and contact Teleflex Medical for instructions on how to return or replace the product.
The recalled product
- Product
- Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product Usage: for use in respiratory and anesthesia circuits to connect two or more components of a breathing system.
- Manufacturer
- Teleflex Medical Europe Ltd
- Affected units
- 103,910
Distribution
Distributed nationwide across the United States.
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