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Recall Observatory FDA recall evidence

Device product

Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements during the patient s hemodialysis treatment.

Z-1776-2018

February 15, 2018

Class II

Product summary

Firm
Transonic Systems Inc
Event
Event 79750
Status
Terminated
Classification
Class II
Quantity
6044
Official record key
device-enforcement:Z-1776-2018

Official wording

Reason: The sterility of the device cannot be assured. There is a potential for an increased risk of infection.

Code information: Lots B151130E2 and B161115E0

Distribution pattern: Worldwide Distribution - USA (nationwide) Distribution and to the states of : NJ, NY, OH, PA, and TX., and to the countries of : Canada, South Korea, Thailand, Australia and Taiwan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The sterility of the device cannot be assured. There is a potential for an increased risk of infection.