Home / Import refusals / 97X-0037283-8/11/1

FDA Import Refusal 97X-0037283-8/11/1 — Welch Allyn Inc (Baxter affiliate)

Welch Allyn Inc (Baxter affiliate) — FEI 2183461

The FDA refused shipment 97X-0037283-8/11/1 from Welch Allyn Inc (Baxter affiliate) (United States) on February 9, 2021. The refused product falls under Devices — ELECTROCARDIOGRAPH. Cited charge: 341 This firm has 5 or more other import refusals on record.

Refusal Details

Date
February 9, 2021
Country
United States
Product Category
Devices
Product Code
74DPS ELECTROCARDIOGRAPH
Charges
341

Recent inspections

  • 1174547 (VAI Fri Jul 15 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1015603 (VAI Fri Apr 07 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 851694 (VAI Wed Sep 18 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 723748 (VAI Tue May 10 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • BUU-1787779-2/10001/1 (Tue Mar 17 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-8416058-3/11/1 (Thu Mar 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-3251221-4/11/1 (Tue Sep 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-2370081-0/11/1 (Thu Oct 22 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • SCS-1748743-2/11/1 (Wed Sep 23 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources