Recall Z-1403-2018— Teleflex Medical Europe Ltd
Class II · Terminated
Class II FDA medical device recall by Teleflex Medical Europe Ltd, initiated 2018-03-27, terminated 2021-05-04. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: These one-way valves may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient..
- Recalling firm
- Teleflex Medical Europe Ltd
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-27
- Terminated
- 2021-05-04
- Firm location
- Athlone, Ireland
Product description
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.
Reason for recall
These one-way valves may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient.
Data sourced from openFDA. This site is unofficial and independent of the FDA.