Home / Import refusals / SCS-4660464-2/11/1

FDA Import Refusal SCS-4660464-2/11/1 — ICU Medical Inc.

ICU Medical Inc. — FEI 3012307300

The FDA refused shipment SCS-4660464-2/11/1 from ICU Medical Inc. (United States) on May 16, 2019. The refused product falls under Devices — ACCESSORIES, PUMP, INFUSION. Cited charges: 118,3280 This firm has 5 or more other import refusals on record.

Refusal Details

Date
May 16, 2019
Country
United States
Product Category
Devices
Product Code
80MRZ ACCESSORIES, PUMP, INFUSION
Charges
118,3280

Recent inspections

  • 1201170 (VAI Fri Mar 03 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1141758 (OAI Fri Apr 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1029368 (NAI Thu Oct 12 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • AEK-8242634-5/11/1 (Tue Feb 11 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 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)
  • EI5-5506310-3/11/1 (Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources