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AirLife

Model 2K8004C2M · Carefusion Corporation · DI 10885403222931

OEV — Cardiopulmonary Resuscitation Aid Kit · Class II · 21 CFR 868.5915

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.

61218242019-01: 0 reports for this device; peer average 1/device2020-03: 0 reports for this device; peer average 1/device2020-04: 0 reports for this device; peer average 2.5/device2020-05: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 1/device2021-01: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 1/device2022-01: 0 reports for this device; peer average 3/device2022-06: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 1/device2023-04: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 4/device2024-01: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 1.33/device2024-07: 0 reports for this device; peer average 4/device2024-08: 0 reports for this device; peer average 4/device2024-11: 0 reports for this device; peer average 6/device2024-12: 0 reports for this device; peer average 4/device2025-01: 0 reports for this device; peer average 3/device2025-02: 0 reports for this device; peer average 1/device2025-04: 0 reports for this device; peer average 4/device2025-05: 0 reports for this device; peer average 9.33/device2025-06: 0 reports for this device; peer average 24/device2025-07: 0 reports for this device; peer average 6/device2025-08: 0 reports for this device; peer average 1/device2025-09: 0 reports for this device; peer average 3/device2025-10: 0 reports for this device; peer average 3.5/device2025-11: 0 reports for this device; peer average 4/device2026-01: 0 reports for this device; peer average 3/device2026-02: 0 reports for this device; peer average 4/device2026-04: 0 reports for this device; peer average 5/device2026-05: 0 reports for this device; peer average 2/device01030405060710111201050809110106020405081101040506070811120102040506070809101101020405
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2020-0301
2020-0402.5
2020-0501
2020-0601
2020-0701
2020-1001
2020-1101
2020-1201
2021-0101
2021-0501
2021-0801
2021-0901
2021-1101
2022-0103
2022-0601
2023-0201
2023-0401
2023-0501
2023-0801
2023-1104
2024-0101
2024-0402
2024-0501
2024-0601.33
2024-0704
2024-0804
2024-1106
2024-1204
2025-0103
2025-0201
2025-0404
2025-0509.33
2025-06024
2025-0706
2025-0801
2025-0903
2025-1003.5
2025-1104
2026-0103
2026-0204
2026-0405
2026-0502
This device (reports/month)Average device in OEV (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Carefusion Corporation

  • Warning Letter 2014-06-06 Carefusion 2200 Inc
  • NAI 2025-09-19 Carefusion Corporation · 1 citations
  • NAI 2025-09-19 Carefusion Corporation · 1 citations
  • NAI 2025-09-18 CareFusion DR 203 LTD · 0 citations
  • VAI 2023-09-29 CareFusion 213, LLC · 5 citations
  • NAI 2022-12-08 CAREFUSION · 0 citations
  • NAI 2022-12-08 CAREFUSION · 0 citations
  • VAI 2022-10-19 Carefusion 2200 Inc · 2 citations
  • NAI 2018-11-15 Carefusion 2200 Inc · 0 citations
  • VAI 2018-09-28 Carefusion Corporation · 2 citations
  • VAI 2018-09-28 Carefusion Corporation · 2 citations
  • NAI 2016-12-15 CareFusion 213, LLC · 0 citations
  • VAI 2015-05-07 Carefusion 2200 Inc · 2 citations
  • NAI 2014-12-11 CareFusion Inc · 0 citations
  • NAI 2014-10-30 CareFusion DR 203 LTD · 0 citations
  • VAI 2014-06-20 Carefusion Corporation · 1 citations
  • VAI 2014-06-20 Carefusion Corporation · 1 citations
  • NAI 2014-03-11 CareFusion 213, LLC · 0 citations
  • OAI 2013-11-05 Carefusion 2200 Inc · 7 citations
  • VAI 2011-09-07 Carefusion 2200 Inc · 3 citations
  • OAI 2010-07-30 Carefusion Corporation · 0 citations