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Centurion Medical Products Corporation

FDA Regulatory Profile

Centurion Medical Products Corporation has 152 FDA recalls (2 Class I), 21 inspections, 3 510(k) clearances and 1 compliance action on record.

Latest recall
Z-1075-2020 · Class II · Dec 11, 2019
Latest inspection
Feb 10, 2023 · NAI
Latest 510(k)
May 17, 2022

Part of the Medline corporate family.

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls152 (2 Class I)Oct 23, 2026Not statedCurrent
510(k) clearances3Oct 4, 2026Not statedCurrent
Inspections21Oct 26, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Related names

NameRecalls510(k)InspectionsComplianceMost recent recall
Medline
parent company		01100—

Recent Recalls

NumberClassProductDate
Z-1075-2020Class IICenturion-Suture Tray DYNDR1210A SUTURING TRAYDec 11, 2019
Z-1073-2020Class IICenturion-Drive Kits DM1005 DAILY LVAD MAINTENANCE KIT DM280A LVAD MANAGEMENT SYSTEM 2-7…Dec 11, 2019
Z-1065-2020Class IICenturion-Incision /Drainage Tray ID1235A ESKENAZI INCISION & DRAINAGE TRAY ID1525 INCISION &…Dec 11, 2019
Z-1077-2020Class IICenturion-Trays EBSI1021 VALVE CHANGE KIT- DOUBLEDec 11, 2019
Z-1058-2020Class IICenturion- Umbilical Trays UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICAL VESSEL…Dec 11, 2019
Z-1046-2020Class IICenturion Dental Kits DH775 PREMIUM DENTAL EXAM TRAY DYKA1169B DENTAL KIT Y 2019011690Dec 11, 2019
Z-1056-2020Class IICenturion- SPEC0002B ARTHROGRAM TRAY SPEC0002B ARTHROGRAM TRAY SPEC0004C ARTHROGRAM TRAY…Dec 11, 2019
Z-1064-2020Class IICenturion-Surgical trays DYNJ04079Z CIRCUMCISION TRAY STERILE DYNJ08835 DEBRIDEMENT TRAY W/SAFETY…Dec 11, 2019
Z-1068-2020Class IICenturion- Uterine Sound 67465 STERILE SIMS UTERINE SOUND (83360) Y 2019032790Dec 11, 2019
Z-1093-2020Class IICenturion- PT225 PAIN MANAGEMENT TRAYDec 11, 2019
Z-1067-2020Class IICenturion- Pathology Container 1150ST STERILE GRADUATED CONTAINER, 32 OZ. 17070 AI OR CARDIAC…Dec 11, 2019
Z-1086-2020Class IICenturion- LC145 STERILE NICU LINE CHANGE KITDec 11, 2019
Z-1080-2020Class IICenturion- HT5555A HYPERALIMENTATION & DRSG CHG TRAYDec 11, 2019
Z-1076-2020Class IICenturion-Trays DYNTray, surgicalJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL DYNJ1000 NEWBORN…Dec 11, 2019
Z-1052-2020Class IICenturion-General Surgery Convenience Kits DYNDH1033B SUBCLAVIAN ON/OFF KIT DYNDH1090A SDS…Dec 11, 2019
Z-1049-2020Class IICenturion- Dressing Change Kits DYNDC1182B PICC INSERTION TRAY DYNDC1251D CENTRAL LINE TRAY…Dec 11, 2019
Z-1095-2020Class IICenturion- P151659 BIOPSY TRAY P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK…Dec 11, 2019
Z-1043-2020Class IICenturion Chest Tube Trays: Kit Code Product CHT1170 CHEST TUBE TRAY…Dec 11, 2019
Z-1069-2020Class IICenturion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY…Dec 11, 2019
Z-1062-2020Class IICenturion-BIOPSY TRAY BT205A MINOR SET UP BIOPSY TRAY BT345A HH PACK BIOPSYDec 11, 2019

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 10, 2023Williamston, MIDevicesNo Action Indicated (NAI)3008403546
Apr 5, 2022Howell, MIDevicesNo Action Indicated (NAI)1824619
Nov 1, 2019Williamston, MIDevicesOfficial Action Indicated (OAI)3008403546
Aug 20, 2019Howell, MIDevicesNo Action Indicated (NAI)1824619
Aug 17, 2018Salisbury, NCDevicesNo Action Indicated (NAI)1038445
Jun 26, 2018Howell, MIDevicesNo Action Indicated (NAI)1824619
Jan 31, 2018Williamston, MIDevicesNo Action Indicated (NAI)3008403546
Feb 14, 2017Salisbury, NCDrugsNo Action Indicated (NAI)1038445
Sep 28, 2016Williamston, MIDevicesVoluntary Action Indicated (VAI)3008403546
Sep 21, 2015Howell, MIDevicesVoluntary Action Indicated (VAI)1824619
Mar 31, 2015Salisbury, NCDevicesVoluntary Action Indicated (VAI)1038445
Mar 26, 2015Howell, MIDevicesOfficial Action Indicated (OAI)1824619
Nov 18, 2013Williamston, MIDevicesVoluntary Action Indicated (VAI)3008403546
Mar 19, 2013Williamston, MIDevicesVoluntary Action Indicated (VAI)3008403546
Jun 29, 2012Howell, MIDevicesVoluntary Action Indicated (VAI)1824619
Dec 16, 2011Salisbury, NCDrugsNo Action Indicated (NAI)1038445
Jun 2, 2011Williamston, MIDevicesNo Action Indicated (NAI)3008403546
Jun 28, 2010Salisbury, NCDevicesVoluntary Action Indicated (VAI)1038445
Mar 8, 2010Howell, MIDevicesNo Action Indicated (NAI)1824619
Feb 11, 2010Howell, MIDrugsNo Action Indicated (NAI)1824619

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K210548Medline Integrated Arterial CatheterMay 17, 2022
K161408Compass Cast and MAPNov 22, 2016
K103562CENTURION PRESSURE INJECTABLE EXTENSION SETJun 23, 2011

FDA data resources