Home / Import refusals / AEK-0391385-0/11/1

FDA Import Refusal AEK-0391385-0/11/1 — Covidien, LP

Covidien, LP — FEI 1219930

The FDA refused shipment AEK-0391385-0/11/1 from Covidien, LP (United States) on February 3, 2022. The refused product falls under Devices — STAPLE, IMPLANTABLE. Cited charges: 118,3280,341 This firm has 5 or more other import refusals on record.

Refusal Details

Date
February 3, 2022
Country
United States
Product Category
Devices
Product Code
79GDW STAPLE, IMPLANTABLE
Charges
118,3280,341

Recent inspections

  • 1255834 (NAI Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1118427 (VAI Fri Feb 28 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 891371 (NAI Thu Aug 14 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 812526 (NAI Thu Dec 06 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 767957 (OAI Thu Feb 09 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • SCS-6646173-6/11/1 (Thu Nov 21 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-2601515-8/21/1 (Mon Oct 07 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 231-7179998-0/11/1 (Thu Mar 09 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-2389325-9/11/1 (Fri Dec 30 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-8430821-2/21/1 (Thu Jul 14 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources