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CARDINAL HEALTH

Model 4381 · Cardinal Health 200, LLC · DI 50630140927162

FXY — Hood, Surgical · Class II · 21 CFR 878.4040

UDILibrary device dossier · generated 2026-09-06 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

01112019-04: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1/device2020-04: 0 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 1/device2024-01: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1/device2025-04: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 1/device04100407011001040710010407
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0401
2019-1001
2020-0401
2022-0701
2023-0101
2023-1001
2024-0101
2024-0401
2024-0701
2024-1001
2025-0101
2025-0401
2025-0701
This device (reports/month)Average device in FXY (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Cardinal Health 200, LLC

  • Warning Letter 2024-04-24 Cardinal Health 200, LLC
  • Warning Letter 2024-04-24 Cardinal Health 200, LLC
  • OAI 2023-12-20 Cardinal Health 200, LLC · 3 citations
  • OAI 2023-12-20 Cardinal Health 200, LLC · 3 citations
  • VAI 2023-10-26 Aero-Med LLC · 2 citations
  • NAI 2023-05-05 Cardinal Health 200, LLC · 0 citations
  • NAI 2023-05-05 Cardinal Health 200, LLC · 0 citations
  • NAI 2023-01-12 Ludlow Technical Products Canada, Ltd. (A Division of Cardinal Health LLC) · 0 citations
  • NAI 2020-02-19 Cardinal Health Inc. · 0 citations
  • VAI 2018-12-21 Aero-Med LLC · 2 citations
  • VAI 2017-11-15 Cardinal Health LLC · 1 citations
  • NAI 2017-07-13 Cardinal Health D.R. 203 II LTD · 0 citations
  • VAI 2017-01-25 Cardinal Health · 4 citations
  • NAI 2016-11-16 Cardinal Health Ireland Manufacturing Limited · 0 citations
  • VAI 2016-11-16 Cardinal Health PR 218 Inc · 0 citations
  • NAI 2016-08-25 Cardinal Health 200, LLC · 0 citations
  • NAI 2016-08-25 Cardinal Health 200, LLC · 0 citations
  • NAI 2016-08-23 Cardinal Health 200, LLC · 0 citations
  • VAI 2016-05-12 Cardinal Health · 0 citations
  • NAI 2016-03-23 Cardinal Health LLC · 0 citations
  • VAI 2016-01-28 Ludlow Technical Products Canada, Ltd. (A Division of Cardinal Health LLC) · 2 citations
  • NAI 2015-11-18 Cardinal Health · 0 citations