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Centurion

Model RI1000 · CENTURION MEDICAL PRODUCTS CORPORATION · DI 00653160177169

LJH — System, Irrigation, Urological · Class II · 21 CFR 876.5130

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 (3)

InitiatedRecall #ClassStatusReasonLink basis
2013-05-15Z-1682-2013Class IITerminatedA firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.k number procode
2013-05-15Z-1683-2013Class IITerminatedA firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.k number procode
2013-05-15Z-1684-2013Class IITerminatedA firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.k number procode

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.

23562019-01: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 1/device2020-04: 0 reports for this device; peer average 1/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 2/device2020-10: 0 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 2/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/device2021-07: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 1.5/device2023-03: 0 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 1/device2023-06: 0 reports for this device; peer average 2/device2023-07: 0 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 2.5/device2024-10: 0 reports for this device; peer average 6/device2024-12: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1.5/device2025-03: 0 reports for this device; peer average 1.5/device2025-05: 0 reports for this device; peer average 1/device2025-06: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 1/device2025-11: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 3/device2026-04: 0 reports for this device; peer average 1.5/device01101104080910111201050702091011120203050607081011120206101201030506070810110204
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-1001
2019-1101
2020-0401
2020-0801
2020-0902
2020-1001
2020-1102
2020-1201
2021-0101
2021-0501
2021-0701
2022-0201
2022-0901
2022-1001
2022-1101
2022-1201
2023-0201.5
2023-0302
2023-0501
2023-0602
2023-0701
2023-0801
2023-1001
2023-1101
2023-1201
2024-0201
2024-0602.5
2024-1006
2024-1201
2025-0101.5
2025-0301.5
2025-0501
2025-0602
2025-0701
2025-0801
2025-1001
2025-1101
2026-0203
2026-0401.5
This device (reports/month)Average device in LJH (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — CENTURION MEDICAL PRODUCTS CORPORATION

  • Warning Letter 2020-06-11 Centurion Medical Products, LP
  • NAI 2023-02-10 Centurion Medical Products, LP · 0 citations
  • NAI 2022-04-05 Centurion Medical Products, LP · 0 citations
  • OAI 2019-11-01 Centurion Medical Products, LP · 5 citations
  • OAI 2019-08-20 Centurion Medical Products, LP · 5 citations
  • NAI 2018-08-17 Centurion Medical Products LP · 0 citations
  • NAI 2018-06-26 Centurion Medical Products, LP · 0 citations
  • NAI 2018-01-31 Centurion Medical Products, LP · 0 citations
  • VAI 2016-09-28 Centurion Medical Products, LP · 8 citations
  • VAI 2015-09-21 Centurion Medical Products, LP · 1 citations
  • VAI 2015-03-31 Centurion Medical Products LP · 4 citations
  • OAI 2015-03-26 Centurion Medical Products, LP · 0 citations
  • VAI 2013-11-18 Centurion Medical Products, LP · 0 citations
  • VAI 2013-03-19 Centurion Medical Products, LP · 5 citations
  • VAI 2012-06-29 Centurion Medical Products, LP · 0 citations
  • NAI 2011-06-02 Centurion Medical Products, LP · 0 citations
  • VAI 2010-06-28 Centurion Medical Products LP · 8 citations
  • NAI 2010-03-08 Centurion Medical Products, LP · 0 citations