Recall Z-0419-2016— Teleflex Medical
Class II · Terminated
Class II FDA medical device recall by Teleflex Medical, initiated 2014-04-17, terminated 2015-12-16. It names one FDA 510(k) clearance: K031383. Product: Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit with Column. Reason: Product is being recalled due to complaints that the inspiratory and expiratory tubes are transposed..
- Recalling firm
- Teleflex Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-17
- Terminated
- 2015-12-16
- Firm location
- Durham, NC, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit with Column
Reason for recall
Product is being recalled due to complaints that the inspiratory and expiratory tubes are transposed.
Data sourced from openFDA. This site is unofficial and independent of the FDA.