CLASS II Device recall · Reported 12 Feb 2020 · FDA Enforcement Report

Centurion-General Surgery Convenience Kits DYNDH1033B recalled

Centurion Medical Products is recalling Centurion-General Surgery Convenience Kits DYNDH1033B Subclavian ON/OFF KIT DYNDH1090A, distributed nationwide in the US. The recall was initiated on 11 Dec 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: DYNDH1033B SUBCLAVIAN ON/OFF KIT 2019061080 DYNDH1090A SDS PROCEDURE PACK 2019021990 DYNDH1110 BIOPSY PACK 2019032990 DYNDH1110 BIOPSY PACK 2019011590 DYNDH1110 BIOPSY PACK 2018092590 DYNDH1114 BIOPSY TRAY 2018111290 DYNDH1131 WDC ULTRASOUND KIT 2019030690 DYNDH1227A HOLSTON MYELOGRAM PACK 2019061090 DYNDH1227A HOLSTON MYELOGRAM PACK 2019022790 DYNDH1265 MYELOGRAM TRAY 2018101990 DYNDH1272 LUMBAR PUNCTURE TRAY 2019020590 DYNDH1281A PARA/THORA ULTRASOUND 2019040180 DYNDH1285A BIOPSY ULTRASOUND 2019051380 DYNDH1321 LUMBAR PUNCTURE TRAY 2019011590 DYNDH1349 ARTHROGRAM TRAY 2018121390 DYNDH1359 DIAGNOSTIC TRAY 2019040290 DYNDH1397 GENERAL ASPIRATION TRAY - CHOICE 2019031880 DYNDH1399 ARTHROGRAM TRAY 2019042290
Quantity recalledN/A

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1052-2020
FDA event ID
84530
Recalling firm
Centurion Medical Products, Williamston, MI
Classification
Class II
Status
Terminated
Recall initiated
11 Dec 2019
FDA classified
5 Feb 2020
Reported
12 Feb 2020
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

11 Dec 2019Recall initiated by company
5 Feb 2020Classified by FDA+56 days
12 Feb 2020Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Incomplete seals on the sterile package may compromise the sterility

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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 DYNDH1272 LUMBAR PUNCTURE TRAY DYNDH1281A PARA/THORA ULTRASOUND DYNDH1285A BIOPSY ULTRASOUND DYNDH1321 LUMBAR PUNCTURE TRAY DYNDH1349 ARTHROGRAM TRAY DYNDH1359 DIAGNOSTIC TRAY DYNDH1397 GENERAL ASPIRATION TRAY - CHOICE DYNDH1399 ARTHROGRAM TRAY

Where it was distributed

Nationwide Foreign: GHANA

Nationwide

Questions about this recall

Why was it recalled?

Incomplete seals on the sterile package may compromise the sterility

Which lots are affected?

Lot Numbers: DYNDH1033B SUBCLAVIAN ON/OFF KIT 2019061080 DYNDH1090A SDS PROCEDURE PACK 2019021990 DYNDH1110 BIOPSY PACK 2019032990 DYNDH1110 BIOPSY PACK 2019011590 DYNDH1110 BIOPSY PACK 2018092590 DYNDH1114 BIOPSY TRAY 2018111290 DYNDH1131 WDC ULTRASOUND KIT 2019030690 DYNDH1227A HOLSTON MYELOGRAM PACK 2019061090 DYNDH1227A HOLSTON MYELOGRAM PACK 2019022790 DYNDH1265 MYELOGRAM TRAY 2018101990 DYNDH1272 LUMBAR PUNCTURE TRAY 2019020590 DYNDH1281A PARA/THORA ULTRASOUND 2019040180 DYNDH1285A BIOPSY ULTRASOUND 2019051380 DYNDH1321 LUMBAR PUNCTURE TRAY 2019011590 DYNDH1349 ARTHROGRAM TRAY 2018121390 DYNDH1359 DIAGNOSTIC TRAY 2019040290 DYNDH1397 GENERAL ASPIRATION TRAY - CHOICE 2019031880 DYNDH1399 ARTHROGRAM TRAY 2019042290

Where was it sold?

Nationwide Foreign: GHANA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

53 other products · FDA event 84530

This product is part of a recall event; the main page for the event is Centurion- Umbilical Trays UVT1045 Umbilical Artery Tray recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IICenturion- Umbilical Trays UVT1045 Umbilical Artery Tray recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion- ENT SNUF3 Snuffer KIT Y recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion- HT5555A Hyperalimentation & Drsg Chg Tray recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion- Skin Prep Kits SB1280 Skin Scrub Kit SB1525 recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion- Dressing Change Tray DT10290S Central Line recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion- Biopsy Tray TRIBT170 Biopsy Tray recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion Chest Tube Trays: Kit recalled by Centurion Medical ProductsCenturion Medical ProductsSterilityNationwide
CLASS IICenturion- Driveline System Kit TRIDM250 Outpatient recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion- Umbilical Vessel UPC175 Umbilical Vessel Cath recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion- OR2020 Basin SET recalled by Centurion Medical ProductsCenturion Medical ProductsSterilityNationwide
CLASS IICenturion-Vaginal Speculum VS2000LST Sterile ER Vaginal recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion- Port Draw Kit KNV30 Port Draw Kit recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion- LC145 Sterile Nicu Line Change Kit recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion-Pelvic PE120 Large/Medium Pelvic Tray PE2200 recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion- Circumcision Tray Kits DYNDF1078C Circumcision recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion-Blood Culture Collection Kit BP115 Blood Culture recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion-Trays DYNTray, surgicalJ08835 Debridement Tray recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion- Uterine Sound 67465 Sterile Sims Uterine Sound recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion- Trach Kits TC6282G Tracheostomy Care Tray TC7170 recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion- Dressing Change Kits DYNDC1182B PICC Insertion recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion- Dressing Tray M101156A Dressing Tray M101167A recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion- Nasal Speculum NSP500ST Sterile Nasal Speculum recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion IVS3505 Ultrasound Guided Piv Kit recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion Circumsion Trays as follows: Kit recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion-Pitcher Kit GR100150ST Graduated Pitcher Sterile recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion-Suture Trays SUT10140 Suture Tray SUT10290 recalledCenturion Medical ProductsForeign MaterialNationwide
CLASS IICenturion- Dressing Change Kit BSICVC1005A Cvc Dressing recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion-Surgical Tray MNS10255 Delivery Tray MNS10255 recalledCenturion Medical ProductsForeign MaterialNationwide
CLASS IICenturion-Surgical trays DYNJ04079Z Circumcision Tray recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion Dental Kits DH775 Premium Dental Exam Tray recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion- Laceration Trays DYNDL1073 Laceration Tray recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion- P151659 Biopsy Tray P243133 Latex Tubing Pack recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion-Skin Prep Trays SP1180 Dry Prep Set SP200 Skin recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion- Trach Kits TC6282G Tracheostomy Care Tray TC7170 recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion-Medicine Cup GMC205 Sterile recalledCenturion Medical ProductsForeign MaterialNationwide
CLASS IICenturion-Infant Feeding Kit IFK840 Infant Feeding Kit recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion- PT225 Pain Management Tray recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion-Suture Tray DYNDR1210A Suturing Tray recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion-Skin Prep Tray DYNDP1015 Skin Prep Tray recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion Neonatal PICC Tray recalled by Centurion Medical ProductsCenturion Medical ProductsSterilityNationwide
CLASS IICenturion- UVT1045 Umbilical Artery Tray UVT1055 Uvc Kit recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion-Trays EBSI1021 Valve Change Kit- Double recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion-Incision /Drainage Tray ID1235A Eskenazi Incision recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion PICC : CVI2650 Angio Tray CVI3610 Central Line recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion-Drive Kits DM1005 Daily Lvad Maintenance Kit recalledCenturion Medical ProductsLead & Heavy MetalsNationwide
CLASS IICenturion- I86625 Debridement Tray recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion-Biopsy Tray BT205A Minor Set UP Biopsy Tray recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion-_General Surgery Trays DYNDA1127A Radiology Cut recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion- Pathology Container 1150ST Sterile Graduated recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion-Irrigation Kit IG25STSS Irrigation Gun &Valve Set recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion- SPEC0002B Arthrogram Tray SPEC0002B Arthrogram recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion- Pelvic Exam Kits DYNDE1037 Pelvic Exam recalledCenturion Medical ProductsSterilityNationwide
CLASS IICenturion-Lvad Kits DM1005 Daily Lvad Maintenance Kit recalledCenturion Medical ProductsLead & Heavy MetalsNationwide

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DeviceCLASS IICenturion- Pelvic Exam Kits DYNDE1037 Pelvic Exam recalledCenturion Medical ProductsSterilityNationwide
DeviceCLASS IICenturion- SPEC0002B Arthrogram Tray SPEC0002B Arthrogram recalledCenturion Medical ProductsSterilityNationwide
DeviceCLASS IICenturion-Irrigation Kit IG25STSS Irrigation Gun &Valve Set recalledCenturion Medical ProductsSterilityNationwide

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