FDAFDA · Food and drugs·Recall number Z-2107-2014
Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas Humidifier, (Direct Patient Interface)]. 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 Concha Column Humidifier.
Published July 30, 2014 · Recall initiated: July 9, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The temperature probe does not properly connect to the temperature port.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teleflex Medical
- Distributor
- Worldwide Distribution - US including the states of CA, FL, KS, KY, MA, MI, MO, NC, NE, NJ, NY, OH, PA, TN, TX and VA, and the countries of Argentina, Chile, Colombia, and the Philippines
- Lot
- Catalog Number: 780-96, Lot numbers: 02L1300073 & 02A140133.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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