Home / Import refusals / 799-2626188-3/11/1

FDA Import Refusal 799-2626188-3/11/1 — Terumo Cardiovascular Systems Corporation

Terumo Cardiovascular Systems Corporation — FEI 1828100

The FDA refused shipment 799-2626188-3/11/1 from Terumo Cardiovascular Systems Corporation (United States) on May 26, 2021. The refused product falls under Devices — CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS. Cited charge: 3280

Refusal Details

Date
May 26, 2021
Country
United States
Product Category
Devices
Product Code
74DTQ CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
Charges
3280

Recent inspections

  • 1147794 (NAI Wed Jul 14 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1111814 (NAI Fri Oct 11 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1031879 (NAI Tue Oct 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 996655 (NAI Wed Dec 07 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 971672 (NAI Fri May 13 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

  • Injunction (138) (Tue Mar 29 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources