Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

(Design) Cardinal Wings

Model TRUBREZ · Cardinal Health 200, LLC · DI 20885380190923

KME — Bedding, Disposable, Medical · Class I · 21 CFR 880.6060

UDILibrary device dossier · generated 2026-09-15 · 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.

12342019-04: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 1/device2020-05: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 3/device2021-10: 0 reports for this device; peer average 2/device2022-10: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 4/device2023-07: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 2/device2024-12: 0 reports for this device; peer average 2/device0410020509101003071012
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
2020-0201
2020-0501
2021-0903
2021-1002
2022-1002
2023-0304
2023-0701
2023-1002
2024-1202
This device (reports/month)Average device in KME (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