Home / Import refusals / AEK-8242634-5/11/1

FDA Import Refusal AEK-8242634-5/11/1 — ICU Medical Inc

ICU Medical Inc — FEI 2183161

The FDA refused shipment AEK-8242634-5/11/1 from ICU Medical Inc (United States) on February 11, 2025. The refused product falls under Devices — PUMP, INFUSION. Cited charges: 3280,341 This firm has 5 or more other import refusals on record.

Refusal Details

Date
February 11, 2025
Country
United States
Product Category
Devices
Product Code
80FRN PUMP, INFUSION
Charges
3280,341

Recent inspections

  • 1252032 (NAI Tue Oct 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1207688 (VAI Fri Jun 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1083812 (NAI Wed Feb 13 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1047692 (VAI Wed Apr 11 2018 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • EI5-5506310-3/21/1 (Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EI5-5506310-3/21/2 (Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EI5-5506310-3/31/1 (Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SCS-7330704-7/11/1 (Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • EI5-5506310-3/11/1 (Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources