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Recall Observatory FDA recall evidence

Device product

Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit with Column

Z-0419-2016

April 17, 2014

Class II

Product summary

Firm
Teleflex Medical
Event
Event 72731
Status
Terminated
Classification
Class II
Quantity
2,600 ea
Official record key
device-enforcement:Z-0419-2016

Official wording

Reason: Product is being recalled due to complaints that the inspiratory and expiratory tubes are transposed.

Code information: Lot Numbers : 02K1300128 and 02L1302324

Distribution pattern: US Distribution to the states of : AL, AZ, CA, GA, IL, KY, LA, MA, MI, MN, NJ, NY, NC, OH, OK, OR, PA, TN, TX and WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product is being recalled due to complaints that the inspiratory and expiratory tubes are transposed.