Home / Import refusals / AEK-5125368-7/11/1

FDA Import Refusal AEK-5125368-7/11/1 — Boston Scientific Ltd.

Boston Scientific Ltd. — FEI 3002618605

The FDA refused shipment AEK-5125368-7/11/1 from Boston Scientific Ltd. (Ireland) on September 12, 2018. The refused product falls under Devices — PROSTHESIS, PENILE. Cited charges: 118,508 This firm has 5 or more other import refusals on record.

Refusal Details

Date
September 12, 2018
Country
Ireland
Product Category
Devices
Product Code
78FAE PROSTHESIS, PENILE
Charges
118,508

Recent inspections

  • 1034546 (NAI Thu Jul 27 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 818503 (NAI Thu Jan 17 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 717007 (NAI Thu Feb 17 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 799-2350966-8/10002/1 (Tue Jan 13 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • AEK-3410642-5/11/1 (Wed Jun 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • AEK-4653739-2/11/1 (Fri Aug 24 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • AEK-1143705-6/1/2 (Wed Mar 12 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-0414838-7/1/2 (Mon Dec 17 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources