Home / Import refusals / SCS-3988761-2/10003/1

FDA Import Refusal SCS-3988761-2/10003/1 — Datex-Ohmeda, Inc.

Datex-Ohmeda, Inc. — FEI 2112667

The FDA refused shipment SCS-3988761-2/10003/1 from Datex-Ohmeda, Inc. (United States) on October 10, 2025. The refused product falls under Devices — VAPORIZER, ANESTHESIA, NON-HEATED. Cited charges: 118,3280 This firm has 5 or more other import refusals on record.

Refusal Details

Date
October 10, 2025
Country
United States
Product Category
Devices
Product Code
73CAD VAPORIZER, ANESTHESIA, NON-HEATED
Charges
118,3280

Recent inspections

  • 1223234 (VAI Fri Nov 17 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1200471 (NAI Wed Mar 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1169942 (NAI Wed May 04 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1064872 (NAI Fri Aug 03 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 930736 (VAI Fri Jun 12 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 799-0974806-7/2/1 (Thu Nov 07 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-5960513-2/1/6 (Tue Mar 13 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-5960513-2/1/7 (Tue Mar 13 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-5960513-2/1/8 (Tue Mar 13 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-5960513-2/1/9 (Tue Mar 13 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources