Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Transonic ADT 1018 Flow QC Clear Advantage Tubingsee related information
Date Initiated by FirmFebruary 15, 2018
Create DateMay 09, 2018
Recall Status1 Terminated 3 on April 30, 2019
Recall NumberZ-1776-2018
Recall Event ID 79750
510(K)NumberK021571 
Product Classification Hemodialysis Catheter Luer End Cap - Product Code PEH
ProductTransonic 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
FEI Number 1319030
Recalling Firm/
Manufacturer		 Transonic Systems Inc
34 Dutch Mill Rd
Ithaca NY 14850-9785
For Additional Information ContactMr. 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
ActionThe 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 Commerce6044
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = PEH
-
-