Home / Recalls / Transonic Systems Inc / Z-1776-2018

Z-1776-2018 Class II Terminated

Recalled by Transonic Systems Inc — Ithaca, NY

Recall Details

Product Type
Devices
Report Date
May 16, 2018
Initiation Date
February 15, 2018
Termination Date
April 30, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6044

Product Description

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.

Reason for Recall

The sterility of the device cannot be assured. There is a potential for an increased risk of infection.

Distribution Pattern

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.

Code Information

Lots B151130E2 and B161115E0

Other recalls by Transonic Systems Inc

  • Z-2721-2015 Class II — Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to meas (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-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-2729-2015 Class II — Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to mea (July 27, 2015)
  • Z-2722-2015 Class II — Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to mea (July 27, 2015)