Device recall: Centurion Circumsion Trays as follows: Kit Code Product CIT1270 CIRCUMCISION TRAY CIT2365 CIRCUMCISION TRAY CIT2465…
Class II FDA enforcement event 84530. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Incomplete seals on the sterile package may compromise the sterility
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Centurion Medical Products Corporation started this device recall on 11 Dec 2019. The firm address in the FDA record is in Williamston, MI. FDA put the recall in Class II. FDA event 84530 has 54 product records. The first FDA enforcement report date is 12 Feb 2020. The record gives the status Terminated, with the termination date 4 Sep 2020.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide Foreign: GHANA
Recalling firm
Centurion Medical Products Corporation, Williamston, MI.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
54 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1042-2020 | Centurion Circumsion Trays as follows: Kit Code Product CIT1270 CIRCUMCISION TRAY CIT2365 CIRCUMCISION TRAY CIT2465 CIRCUMCISION TRAY CIT2470 CIRC TRAY W/UNIVERSAL CLAMP CIT2480 CIRCUMCISION TRAY W/CLAMP & 1.3 CM BELL CIT2480 CIRCUMCISION TRAY W/CLAMP & 1.3 CM BELL CIT2510 CIRCUMCISION TRAY W/1.1 CM CLAMP CIT2530A… | 1986 | Class II | Terminated | 12 Feb 2020 |
| Z-1043-2020 | Centurion Chest Tube Trays: Kit Code Product CHT1170 CHEST TUBE TRAY CHT1700 CHEST TUBE INSERTION TRAY CHT1760 CHEST TRAY CHT275 CHEST TUBE INSERTION TRAY CHT440 CHEST TUBE INSERTION TRAY CHT701 CHEST TUBE INSERTION TRAY CHT760 CHEST TUBE INSERTION TRAY CHT940 CHEST TUBE INSERTION TRAY | 448 | Class II | Terminated | 12 Feb 2020 |
| Z-1044-2020 | Centurion Neonatal PICC Tray: CVI2310 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI2550 NEONATAL PICC INSERTION TRAY CVI3650 PEDS PICC INSERTION TRAY CVI3730 NEONATAL PICC LINE TRAY CVI4235 NEONATAL PROCEDURE PICC TRAY… | 957 | Class II | Terminated | 12 Feb 2020 |
| Z-1045-2020 | Centurion PICC : CVI2650 ANGIO TRAY CVI3610 CENTRAL LINE INSERTION BUNDLE CVI4025 PICC INSERTION BUNDLE (P/S) CVI4190 CENTRAL LINE INSERTION BUNDLE CVI4190 CENTRAL LINE INSERTION BUNDLE CVI4330 PICC INSERTION TRAY CVI4340 MIDLINE INSERTION TRAY CVI4485 MOUNT SINAI CVP INSERTION KIT CVI515 VENOUS ACCESS KIT CVI650… | 29020 | Class II | Terminated | 12 Feb 2020 |
| Z-1046-2020 | Centurion Dental Kits DH775 PREMIUM DENTAL EXAM TRAY DYKA1169B DENTAL KIT Y 2019011690 | 1720 | Class II | Terminated | 12 Feb 2020 |
| Z-1047-2020 | Centurion- Dressing Change Tray DT10290S CENTRAL LINE PREPARATION PACK DT10290S CENTRAL LINE PREPARATION PACK DT10415 PICC INSERTION TRAY DT10495 PICC INSERTION TRAY DT10525 CENTRAL LINE INSERTION DRAPE KIT DT10675 CENTRAL LINE INSERTION PROCEDURE KIT DT10755 DRESS UP KIT DT10850 PORT DRESSING CHANGE TRAY DT10850… | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1048-2020 | Centurion-_General Surgery Trays DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 DYNDA1178 ICIO TRAY DYNDA1183 AUXILARY TOWEL PACK DYNDA1223 CUSTOM PREP CUP KIT DYNDA1223 CUSTOM PREP CUP KIT DYNDA1246A CIRCUMCISION PACK DYNDA1349A CIRCUMCISION TRAY DYNDA1388 STERILE EK DOUBLE PACK DYNDA1615 STERILE BARRIER KIT DYNDA1615… | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1049-2020 | Centurion- Dressing Change Kits DYNDC1182B PICC INSERTION TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1251D CENTRAL LINE TRAY DYNDC1586C CENTRAL LINE DRESSING NGE TRAY DYNDC1597A CVC DRESSING CHANGE TRAY DYNDC1796C TRAY, CENTRAL LINE DYNDC1796C TRAY, CENTRAL LINE DYNDC1800 TRAY,PORT-A-CATH ACCESS DYNDC1855A CVC DRESSING… | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1050-2020 | Centurion- Pelvic Exam Kits DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2019032090 DYNDE1037 PELVIC EXAM TRAY,UNIVERSITY H 2018091790 | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1051-2020 | Centurion- Circumcision Tray Kits DYNDF1078C CIRCUMCISION TRAY DYNDF1082 CIRCUMCISION TRAY DYNDF1082 CIRCUMCISION TRAY DYNDF1093C UNIVERSAL CIRCUMCISION TRAY W/O CLAMP DYNDF1093C UNIVERSAL CIRCUMCISION TRAY W/O CLAMP DYNDF1109 TRAY,CIRCUMCISION DYNDF1128 CIRCUMCISION TRAY | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1052-2020 | Centurion-General Surgery Convenience Kits DYNDH1033B SUBCLAVIAN ON/OFF KIT DYNDH1090A SDS PROCEDURE PACK DYNDH1110 BIOPSY PACK DYNDH1110 BIOPSY PACK DYNDH1110 BIOPSY PACK DYNDH1114 BIOPSY TRAY DYNDH1131 WDC ULTRASOUND KIT DYNDH1227A HOLSTON MYELOGRAM PACK DYNDH1227A HOLSTON MYELOGRAM PACK DYNDH1265 MYELOGRAM TRAY… | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1053-2020 | Centurion- Laceration Trays DYNDL1073 LACERATION TRAY DYNDL1152A LACERATION TRAY DYNDL1152A LACERATION TRAY DYNDL1223A LACERATION TRAY DYNDL1295B KIT,PAIN DYNDL1436A LACERATION TRAY DYNDL1436A LACERATION TRAY DYNDL1600B RCHSD CVP TRAY DYNDL1606A VAGINAL DELIVERY TRAY DYNDL1617A PICC INSERTION KIT-LATEX FREE… | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1054-2020 | Centurion-Surgical Tray MNS10255 DELIVERY TRAY MNS10255 DELIVERY TRAY MNS10310 MEATOTOMY TRAY MNS10310 MEATOTOMY TRAY MNS10525 DELIVERY INSTRUMENT TRAY MNS10620 PACEMAKER TRAY MNS10820 ENT/EPISTAXIS KIT MNS10920 PODIATRY NAIL PACK MNS10985 CERCLAGE REMOVAL KIT MNS11020 VAGINAL DELIVERY TRAY MNS11040 OB DELIVERY… | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1055-2020 | Centurion-Pelvic PE120 LARGE/MEDIUM PELVIC TRAY PE2200 PELVIC EXAM TRAY PE2200 PELVIC EXAM TRAY PE2400 PELVIC EXAM TRAY PE2515 SMALL GYN EXAM TRAY PE2515 SMALL GYN EXAM TRAY PE2610 PELVIC EXAM TRAY PE2700 ULTRASOUND TRAY PE2700 ULTRASOUND TRAY PE2820 VAG/VIRGIN VAG EXAM TRAY PE2835 PELVIC EXAM TRAY PE2835 PELVIC EXAM… | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1056-2020 | Centurion- SPEC0002B ARTHROGRAM TRAY SPEC0002B ARTHROGRAM TRAY SPEC0004C ARTHROGRAM TRAY SPEC0071B CUSTOM BX TRAY SPEC0076G STEREO BIOPSY PACK-LF SPEC0122 BASIC BIOPSY TRAY SPEC0130B BREAST BIOPSY TRAY SPEC0158A CT BIOPSY TRAY SPEC0248B GENERAL BIOPSY TRAY- LF SPEC0265A 22G FACET TRAY SPEC0313 CYST ASPIRATION TRAY-LF… | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1057-2020 | Centurion-Suture Trays SUT10140 SUTURE TRAY SUT10290 LACERATION TRAY SUT10705 SUTURING TRAY SUT10770 DEBRIDEMENT/SUTURE SET SUT10795 PORT IMPLANT SET SUT11035 SUTURE TRAY SUT11065 LACERATION TRAY SUT1113A SUTURING SET SUT11145 SNAGFREE SUTURE SET W/SURGICAL INST. SUT11515 LACERATION TRAY SUT11540A LACERATION TRAY… | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1058-2020 | Centurion- Umbilical Trays UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICAL VESSEL CATHETER TRAY UVT170 UMBILICAL VESSEL TRAY W/O CATHETER UVT280 UMBILICAL ARTERY TRAY UVT460 UMBILICAL CATHETER TRAY UVT505 UMBILICAL VESSEL CATH INSERT TR W/O CATH UVT630 UMBILICAL/PICC/CHEST TUBE INS KIT UVT640… | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1059-2020 | Centurion- Umbilical Vessel UPC175 UMBILICAL VESSEL CATH. INSERTION UPC175 UMBILICAL VESSEL CATH. INSERTION | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1060-2020 | Centurion-BLOOD CULTURE COLLECTION KIT BP115 BLOOD CULTURE COLLECTION KIT | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1061-2020 | Centurion- DRESSING CHANGE KIT BSICVC1005A CVC DRESSING CHANGE KIT NICU BSIPICC1002A PICC DRESSING CHANGE KIT NICU BSIPICC1003A PICC DRESSING CHANGE KIT | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1062-2020 | Centurion-BIOPSY TRAY BT205A MINOR SET UP BIOPSY TRAY BT345A HH PACK BIOPSY | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1063-2020 | Centurion-LVAD Kits DM1005 DAILY LVAD MAINTENANCE KIT DM280A LVAD MANAGEMENT SYSTEM 2-7 DM320 PERCUTANEOUS LEAD MANAGEMENT KIT DM380 DAILY LVAD KIT MORRISTOWN MEDICAL DM405A ADVOCATE CHRIST DAILY WET KIT DM405A ADVOCATE CHRIST DAILY WET KIT DM525 LVAD SENSITIVE KIT DM545 U OF U LVAD SENSITIVE SKIN DRESSING SYST DM550… | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1064-2020 | Centurion-Surgical trays DYNJ04079Z CIRCUMCISION TRAY STERILE DYNJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL DYNJ1000 NEWBORN CIRCUMCISION TRAY | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1065-2020 | Centurion-Incision /Drainage Tray ID1235A ESKENAZI INCISION & DRAINAGE TRAY ID1525 INCISION & DRAINAGE TRAY ID1670 I&D TRAY ID1715 INCISION & DRAINAGE TRAY ID1765 ER I&D PACK ID1765 ER I&D PACK ID1835 I & D TRAY ID2075 I&D TRAY ID585 INCISION & DRAINAGE TRAY ID875 INCISION & DRAINAGE TRAY ID875 INCISION & DRAINAGE TRAY | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1066-2020 | Centurion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY TC7370 TRACHEOSTOMY KIT TC7450 DISPOSABLE TRACH TRAY | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1067-2020 | Centurion- Pathology Container 1150ST STERILE GRADUATED CONTAINER, 32 OZ. 17070 AI OR CARDIAC STERILE KIT 3703ST STERILE PATHOLOGY CONTAINER 3706ST STERILE CONTAINER 165 OZ. | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1068-2020 | Centurion- Uterine Sound 67465 STERILE SIMS UTERINE SOUND (83360) Y 2019032790 | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1069-2020 | Centurion- Trach Kits TC6282G TRACHEOSTOMY CARE TRAY TC7170 LATEX FREE TRACHEOSTOMY CARE TRAY TC7370 TRACHEOSTOMY KIT TC7450 DISPOSABLE TRACH TRAY | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1070-2020 | Centurion- Biopsy Tray TRIBT170 BIOPSY TRAY | 60 | Class II | Terminated | 12 Feb 2020 |
| Z-1071-2020 | Centurion- Driveline System Kit TRIDM250 OUTPATIENT DRIVELINE MGMT SYSTEM | 100 | Class II | Terminated | 12 Feb 2020 |
| Z-1072-2020 | Centurion-Vaginal Speculum VS2000LST STERILE ER VAGINAL SPECULUM W/LIGHT | 1100 | Class II | Terminated | 12 Feb 2020 |
| Z-1073-2020 | Centurion-Drive Kits DM1005 DAILY LVAD MAINTENANCE KIT DM280A LVAD MANAGEMENT SYSTEM 2-7 DM320 PERCUTANEOUS LEAD MANAGEMENT KIT DM380 DAILY LVAD KIT MORRISTOWN MEDICAL DM405A ADVOCATE CHRIST DAILY WET KIT DM405A ADVOCATE CHRIST DAILY WET KIT DM525 LVAD SENSITIVE KIT DM545 U OF U LVAD SENSITIVE SKIN DRESSING SYST… | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1074-2020 | Centurion-Skin Prep Tray DYNDP1015 SKIN PREP TRAY | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1075-2020 | Centurion-Suture Tray DYNDR1210A SUTURING TRAY | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1076-2020 | Centurion-Trays DYNTray, surgicalJ08835 DEBRIDEMENT TRAY W/SAFETY SCAL DYNJ1000 NEWBORN CIRCUMCISION TRAY | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1077-2020 | Centurion-Trays EBSI1021 VALVE CHANGE KIT- DOUBLE | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1078-2020 | Centurion-Medicine Cup GMC205 GLASS MEDICINE CUP 2 OUNCE STERILE | 600 | Class II | Terminated | 12 Feb 2020 |
| Z-1079-2020 | Centurion-Pitcher Kit GR100150ST GRADUATED PITCHER STERILE 1000 CC Y 2018121090 GR1200ST STERILE 1200CC PITCHER KIT Y 2019031990 | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1080-2020 | Centurion- HT5555A HYPERALIMENTATION & DRSG CHG TRAY | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1081-2020 | Centurion- I86625 DEBRIDEMENT TRAY | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1082-2020 | Centurion-Infant Feeding Kit IFK840 INFANT FEEDING KIT (8 FR X 40 IN) | 48 | Class II | Terminated | 12 Feb 2020 |
| Z-1083-2020 | Centurion-Irrigation Kit IG25STSS IRRIGATION GUN &VALVE SET W/SPLASHSHIELD Y | 270 | Class II | Terminated | 12 Feb 2020 |
| Z-1084-2020 | Centurion IVS3505 ULTRASOUND GUIDED PIV KIT | 350 | Class II | Terminated | 12 Feb 2020 |
| Z-1085-2020 | Centurion- Port Draw Kit KNV30 PORT DRAW KIT | 75 | Class II | Terminated | 12 Feb 2020 |
| Z-1086-2020 | Centurion- LC145 STERILE NICU LINE CHANGE KIT | 160 | Class II | Terminated | 12 Feb 2020 |
| Z-1087-2020 | Centurion- Dressing Tray M101156A DRESSING TRAY M101167A DRESSING TRAY M101168A DRESSING TRAY M101170A MAJOR DRESSING TRAY M101170A MAJOR DRESSING TRAY M101170A MAJOR DRESSING TRAY M101170A MAJOR DRESSING TRAY M101172B MINOR CORE DRESSING TRAY M101172B MINOR CORE DRESSING TRAY M101172B MINOR CORE DRESSING TRAY… | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1088-2020 | Centurion- OR2020 BASIN SET | 188 units | Class II | Terminated | 12 Feb 2020 |
| Z-1089-2020 | Centurion- Nasal Speculum NSP500ST STERILE NASAL SPECULUM | 1820 units | Class II | Terminated | 12 Feb 2020 |
| Z-1090-2020 | Centurion- Skin Prep Kits SB1280 SKIN SCRUB KIT SB1525 VAGINAL PREP TRAY | 108 units | Class II | Terminated | 12 Feb 2020 |
| Z-1091-2020 | Centurion- ENT SNUF3 SNUFFER KIT Y | 146 units | Class II | Terminated | 12 Feb 2020 |
| Z-1092-2020 | Centurion-Skin Prep Trays SP1180 DRY PREP SET SP200 SKIN SCRUB TRAY SP415 STERILE GAUZE SPONGE | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1093-2020 | Centurion- PT225 PAIN MANAGEMENT TRAY | 420 units | Class II | Terminated | 12 Feb 2020 |
| Z-1094-2020 | Centurion- UVT1045 UMBILICAL ARTERY TRAY UVT1055 UVC KIT UVT1065 UMBILICAL VESSEL CATHETER TRAY UVT170 UMBILICAL VESSEL TRAY W/O CATHETER UVT280 UMBILICAL ARTERY TRAY UVT460 UMBILICAL CATHETER TRAY UVT505 UMBILICAL VESSEL CATH INSERT TR W/O CATH UVT630 UMBILICAL/PICC/CHEST TUBE INS KIT UVT640 UMBILICAL CATHETER… | N/A | Class II | Terminated | 12 Feb 2020 |
| Z-1095-2020 | Centurion- P151659 BIOPSY TRAY P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P243133 LATEX TUBING PACK P261569 PACK BIOPSY P392929 BMT-LACERATION PACK P429589A TRAY BONE MARRO ASC LTX SAFE P734457 SUTURE REMOVAL PACK LATEX SAFE P751651A BIOPSY PROCEDURE PACK P758486 PVP PREP PACK P758486 PVP PREP PACK P922260… | N/A | Class II | Terminated | 12 Feb 2020 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class II
- 88%
- Product records in this event
- 54Median of the firm: 2
- Events of the firm on the register
- 19
Other events of the firm
Official channels
- FDA enforcement report Z-1042-2020The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 84530. https://recallregister.com/fda/ii/84530/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide Foreign: GHANA
- What quantity of product is in FDA event 84530?
- The event has 54 product records. The first record gives this quantity:
1986
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 88% of the 968 device events that started in 2019 are in Class II.