CLASS II Device recall · Reported 12 Feb 2020 · FDA Enforcement Report
Centurion PICC : CVI2650 Angio Tray CVI3610 Central Line recalled
Centurion Medical Products is recalling Centurion PICC : CVI2650 Angio Tray CVI3610 Central Line Insertion Bundle CVI4025 PICC, 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
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-1045-2020
- 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
- Device type
- Other Medical Devices
Timeline
| 11 Dec 2019 | Recall initiated by company | |
| 5 Feb 2020 | Classified by FDA | +56 days |
| 12 Feb 2020 | Published 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 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 INSERTION TRAY
Where it was distributed
Nationwide Foreign: GHANA
Questions about this recall
Is Centurion PICC : CVI2650 Angio Tray CVI3610 Central Line Insertion Bundle CVI4025 PICC recalled?
Yes. Centurion Medical Products recalled Centurion PICC : CVI2650 Angio Tray CVI3610 Central Line Insertion Bundle CVI4025 PICC on 11 Dec 2019. The recall is Class II and its status is Terminated. Recall number Z-1045-2020.
Why was it recalled?
Incomplete seals on the sterile package may compromise the sterility
Which lots are affected?
Kit Code Product Lot Number DM1005 DAILY LVAD MAINTENANCE KIT N 2019030480 DM280A LVAD MANAGEMENT SYSTEM 2-7 2019010790 DM320 PERCUTANEOUS LEAD MANAGEMENT KIT 2018122890 DM380 DAILY LVAD KIT MORRISTOWN MEDICAL 2019061190 DM405A ADVOCATE CHRIST DAILY WET KIT 2019030480 DM405A ADVOCATE CHRIST DAILY WET KIT 2019012980 DM525 LVAD SENSITIVE KIT N 2019040180 DM545 U OF U LVAD SENSITIVE SKIN DRESSING SYST 2018111290 DM550 VAD DRIVELINE MANAGEMENT TRAY 2018121790 DM555 LVAD MULTI-DAY DRIVELINE MGMT SIZE M/L 2019032290 DM565 LVAD DRESSING SYSTEM Y 2018112890 DM575 LVAD MULTI-DAY DRIVELINE MGMT SIZE S 2019010490 DM610 DRIVELINE MANAGEMENT SYSTEM-DAILY 2019042980 DM610 DRIVELINE MANAGEMENT SYSTEM-DAILY 2019042280 DM610 DRIVELINE MANAGEMENT SYSTEM-DAILY 2019030480 DM690 VAD DRIVELINE MANAGEMENT BUNDLE 2019011790 DM710 VAD DAILY DRESSING CHANGE KIT 2019011790 DM720 DAILY LVAD MAINTENANCE KIT 2018122190 DM765 DAILY DRIVELINE MANAGEMENT SYSTEM 2018112190 DM770 WEEKLY DRIVELINE MANAGEMENT SYSTEM 2018121790 DM775 EXTENDED WEAR DRIVELINE MANAGEMENT KIT 2019030890 DM775 EXTENDED WEAR DRIVELINE MANAGEMENT KIT 2019011890 DM805 DAILY LVAD DRIVELINE MANAGEMENT SYSTEM 2019020480 DM870 DAILY MAINTENANCE SYSTEM LVAD 2018102590 DM920 GAUZE DRIVELINE MANAGEMENT KIT 2019031190 DM925 SORBAVIEW DRIVELINE MANAGEMENT KIT 2018111590 DM935 DAILY DRIVELINE MANAGEMENT SYSTEM 2018110790 DM950 HIGH DRAINAGE LVAD TRAY 2019012590
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.
More recalls from Centurion Medical Products
All 152| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Centurion Difficult IV KIT containing BD's Vacutainer recalled | Centurion Medical Products | Foreign Material | Nationwide |
| Device | CLASS II | Centurion-Lvad Kits DM1005 Daily Lvad Maintenance Kit recalled | Centurion Medical Products | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Centurion- Pelvic Exam Kits DYNDE1037 Pelvic Exam recalled | Centurion Medical Products | Sterility | Nationwide |
| Device | CLASS II | Centurion- SPEC0002B Arthrogram Tray SPEC0002B Arthrogram recalled | Centurion Medical Products | Sterility | Nationwide |
| Device | CLASS II | Centurion-Irrigation Kit IG25STSS Irrigation Gun &Valve Set recalled | Centurion Medical Products | Sterility | Nationwide |
Other Other Medical Devices recalls
All 13,771| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ortho Aspiration Kit recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Arterial Line Insertion Kit recalled | Medline Industries | Sterility | Nationwide |