Device 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 Concha Column Humidifier.
Z-2108-2014
Product summary
- Firm
- Teleflex Medical
- Event
- Event 68731
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,679 units
- Official record key
device-enforcement:Z-2108-2014
Official wording
Reason: The temperature probe does not properly connect to the temperature port.
Code information: Catalog Number: 1696, Lot numbers: 02K1301986, 02L1300010, 02L1300037, 02L1301081, 02L1301783, 02M1300190, 02M1300236, 02A1400518 02A1401286, 02A1402358, 02B1400178, 02B1400715 & 02B1401320.
Distribution pattern: 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
Derived failure modes
-
Unknown
The temperature probe does not properly connect to the temperature port.