FDAFDA · Food and drugs·Recall number Z-1776-2018
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.
Published May 16, 2018 · Recall initiated: February 15, 2018
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 sterility of the device cannot be assured. There is a potential for an increased risk of infection.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Transonic Systems Inc
- Distributor
- 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.
- Lot
- Lots B151130E2 and B161115E0
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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