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.
FDA Recall Z-1776-2018 · Posted None
Recalling FirmTransonic Systems Inc
Recall StatusTerminated
Product CodePEH
Date Initiated2018-02-15
Date Terminated2019-04-30
Product Quantity6044
Reason for Recall
The sterility of the device cannot be assured. There is a potential for an increased risk of infection.
Firm Action
The recalling firm has sent all of its customers a Recall Notification Letter dated February 15, 2018, and has included a Customer Reponse Form that requests that customers either return or destroy the ADT1018 Tubing in their
possession. For further questions, please call (800) 353-3569.
Root Cause
Process control
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.