Z-1776-2018Class II

Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for...

Name: Z-1776-2018 Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for...
Creator: Transonic Systems Inc
Published: 2018-02-15
License: https://open.fda.gov/license/

Transonic Systems Inc / initiated 2018-02-15 / Terminated / root cause: manufacturing process

FDA source

Transonic Systems Inc began a recall of 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... on 2018-02-15. FDA classified it as Class II and gives the reason as "The sterility of the device cannot be assured. There is a potential for an increased risk of infection". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1776-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-15
Posted: 2018-05-09
Terminated: 2019-04-30
Recalling firm: Transonic Systems Inc
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.
Product code: PEH Hemodialysis Catheter Luer End Cap
Reason for recall: The sterility of the device cannot be assured. There is a potential for an increased risk of infection.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Lots B151130E2 and B161115E0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1776-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1776-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-09

Product code PEH

K021571Class IITransonic Flow-Qc Set Model Adt1010Transonic Systems, Inc. / cleared 2002-08-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)