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U.S. Department of Health and Human Services

Class 2 Device Recall Transonic ADT 1018 Flow QC Clear Advantage Tubing

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  Class 2 Device Recall Transonic ADT 1018 Flow QC Clear Advantage Tubing see related information
Date Initiated by Firm February 15, 2018
Create Date May 09, 2018
Recall Status1 Terminated 3 on April 30, 2019
Recall Number Z-1776-2018
Recall Event ID 79750
510(K)Number K021571  
Product Classification Hemodialysis Catheter Luer End Cap - Product Code PEH
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.
Code Information Lots B151130E2 and B161115E0
Recalling Firm/
Manufacturer		 Transonic Systems Inc
34 Dutch Mill Rd
Ithaca NY 14850-9785
For Additional Information Contact Mr. Cornelis Drost
800-353-3569
Manufacturer Reason
for Recall		 The sterility of the device cannot be assured. There is a potential for an increased risk of infection.
FDA Determined
Cause 2		 Process control
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.
Quantity in Commerce 6044
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = PEH and Original Applicant = TRANSONIC SYSTEMS, INC.
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