Z-1147-2013Class II

HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic...

Name: Z-1147-2013 HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic...
Creator: Transonic Systems Inc
Published: 2013-03-28
License: https://open.fda.gov/license/

Transonic Systems Inc / initiated 2013-03-28 / Terminated / root cause: design

FDA source

Transonic Systems Inc began a recall of HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. Product Usage: is... on 2013-03-28. FDA classified it as Class II and gives the reason as "Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1147-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-28
Posted: 2013-04-18
Terminated: 2014-03-05
Recalling firm: Transonic Systems Inc
Product: HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. Product Usage: is indicated for use in patients greater than or equal to 2 years old with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.
Product code: DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Reason for recall: Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.
Root cause tag: design
FDA root cause: Component design/selection
Action: Transonic Systems Inc. sent an Urgent: Medical Device Recall dated March 27, 2013 to all affected customers. The letter identified the recalled product, problem and actions to be taken. Customers were instructed to examine inventory, quarantine, discontinue use and return any recalled product via FedEx. Transonic Systems Inc. has offered to reimburse the firm for the return of these recalled products by check or credit memo for the returned goods and postage. Transonic Systems Inc. has requested that if a firm has further distributed any of the above lots, that they immediately contact their accounts, inform them of the recall, and have them return their outstanding recalled stocks to you. Transonic Systems Inc. have included copies of the product labeling and a Recall Return Response Form in their packet. Completed Recall Return Response Forms should be faxed to 607-257-5310.
Quantity in commerce: 195 units total (140 units Domestic, 55 units Foreign)
Distribution: Worldwide Distribution - USA Nationwide including the states of AZ, CA, FL, GA, NM, NY, TX, VA and WA and countries of Netherlands, Canada and Russia.
Product codes and lots: Lot numbers: 102810, 010311 and 111810.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1147-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1147-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-18

Product code DXG

K080116Class IITransonic Costatus Cardiac Output SystemTransonic Systems, Inc. / cleared 2008-09-08

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)