Home / Import refusals / AEK-4358213-6/11/1

FDA Import Refusal AEK-4358213-6/11/1 — Zoll Medical Corporation

Zoll Medical Corporation — FEI 2112020

The FDA refused shipment AEK-4358213-6/11/1 from Zoll Medical Corporation (United States) on April 2, 2018. The refused product falls under Devices — AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE). Cited charges: 118,237,3280,508 This firm has 5 or more other import refusals on record.

Refusal Details

Date
April 2, 2018
Country
United States
Product Category
Devices
Product Code
74MKJ AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Charges
118,237,3280,508

Recent inspections

  • 1171958 (VAI Mon Jun 13 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 800735 (VAI Tue Sep 18 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 712206 (VAI Tue Jan 11 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 683406 (VAI Fri Dec 17 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 619666 (OAI Thu Oct 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • AEK-0440165-8/10001/1 (Fri May 15 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • MC2-8016312-2/11/1 (Wed Nov 13 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-5298553-8/11/1 (Tue Oct 26 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • MC2-6830930-9/41/1 (Tue Mar 02 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 791-2519221-6/11/1 (Thu Mar 05 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources