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FDA Import Refusal 534-1016342-1/11/1 — ZOLL Medical Corporation

ZOLL Medical Corporation — FEI 1220908

The FDA refused shipment 534-1016342-1/11/1 from ZOLL Medical Corporation (United States) on January 2, 2019. The refused product falls under Devices — VENTILATOR, CONTINUOUS (RESPIRATOR). Cited charges: 118,341 This firm has 5 or more other import refusals on record.

Refusal Details

Date
January 2, 2019
Country
United States
Product Category
Devices
Product Code
73CBK VENTILATOR, CONTINUOUS (RESPIRATOR)
Charges
118,341

Recent inspections

  • 1246565 (OAI Tue Apr 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 992399 (VAI Tue Oct 18 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 982649 (NAI Fri Aug 26 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 966609 (NAI Fri Apr 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 900180 (NAI Thu Aug 07 2014 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