Home / Recalls / Terumo Cardiovascular Systems Corporation / Z-2103-2019

Z-2103-2019 Class II Terminated

Recalled by Terumo Cardiovascular Systems Corporation — Elkton, MD

Recall Details

Product Type
Devices
Report Date
August 7, 2019
Initiation Date
June 14, 2019
Termination Date
June 11, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
78 units

Product Description

Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market

Reason for Recall

Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component

Distribution Pattern

MI Foreign: Japan, Belgium

Code Information

Lot Numbers: XA28, XC12, XC25, XD05, XD27

Other recalls by Terumo Cardiovascular Systems Corporation

  • Z-2018-2025 Class II — CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. (May 28, 2025)
  • Z-1492-2025 Class II — Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catal (March 3, 2025)
  • Z-1401-2024 Class II — Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A Pa (February 20, 2024)
  • Z-1347-2023 Class II — CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC (March 1, 2023)
  • Z-1346-2023 Class II — CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE (March 1, 2023)
  • Z-1345-2023 Class II — CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30 (March 1, 2023)
  • Z-2350-2021 Class II — Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 8 (June 8, 2021)
  • Z-1791-2021 Class II — The Sarns TCM II (system) is a source of temperature-controlled water for blood (April 16, 2021)
  • Z-1789-2021 Class II — The Terumo HX2 Temperature Management System provides temperature control of two (April 16, 2021)
  • Z-1790-2021 Class II — The Sarns Temperature Control and Monitor unit (TCM) is a source of temperature- (April 16, 2021)