Transonic Systems Inc: 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.

Recall number

Z-1147-2013

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.

Status

Terminated

Initiated

2013-03-28

Posted

2013-04-18

Terminated

2014-03-05

Reason

Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.

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

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.

Lot, serial or model codes

Lot numbers: 102810, 010311 and 111810.

510(k) numbers

["K080116"]

PMA numbers

not on file

Product code

DXG

Firm FEI

1319030

Firm city

Ithaca

Firm state

NY

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy