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FDA Import Refusal 231-8519368-2/11/9 — ICU Medical Costa Rica Ltd.

ICU Medical Costa Rica Ltd. — FEI 3002999813

The FDA refused shipment 231-8519368-2/11/9 from ICU Medical Costa Rica Ltd. (Costa Rica) on April 11, 2022. The refused product falls under Devices — SET, ADMINISTRATION, INTRAVASCULAR. Cited charge: 118 This firm has 5 or more other import refusals on record.

Refusal Details

Date
April 11, 2022
Country
Costa Rica
Product Category
Devices
Product Code
80FPA SET, ADMINISTRATION, INTRAVASCULAR
Charges
118

Recent inspections

  • 919381 (NAI Mon Feb 23 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 780800 (OAI Thu Apr 19 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 231-8520374-7/11/3 (Wed Aug 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 231-8519368-2/11/2 (Mon Apr 11 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 231-8519368-2/11/3 (Mon Apr 11 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 231-8519368-2/11/4 (Mon Apr 11 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 231-8519368-2/11/1 (Mon Apr 11 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources