Home / Recalls / Transonic Systems Inc / Z-1147-2013

Z-1147-2013 Class II Terminated

Recalled by Transonic Systems Inc — Ithaca, NY

Recall Details

Product Type
Devices
Report Date
April 24, 2013
Initiation Date
March 28, 2013
Termination Date
March 5, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
195 units total (140 units Domestic, 55 units Foreign)

Product Description

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.

Reason for Recall

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

Distribution Pattern

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.

Code Information

Lot numbers: 102810, 010311 and 111810.

Other recalls by Transonic Systems Inc

  • Z-1776-2018 Class II — Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-4 (February 15, 2018)
  • Z-2727-2015 Class II — Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measu (July 27, 2015)
  • Z-2724-2015 Class II — Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to meas (July 27, 2015)
  • Z-2723-2015 Class II — Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measu (July 27, 2015)
  • Z-2720-2015 Class II — Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measur (July 27, 2015)
  • Z-2725-2015 Class II — Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measur (July 27, 2015)
  • Z-2722-2015 Class II — Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to mea (July 27, 2015)
  • Z-2726-2015 Class II — Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measu (July 27, 2015)
  • Z-2728-2015 Class II — Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure (July 27, 2015)
  • Z-2721-2015 Class II — Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to meas (July 27, 2015)