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Recall Observatory FDA recall evidence

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

July 09, 2014

Class II

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

    reason.no_named_rule · v1.0.0

    The temperature probe does not properly connect to the temperature port.