Centurion-Drive Kits DM1005 DAILY LVAD MAINTENANCE KIT DM280A LVAD MANAGEMENT SYSTEM 2-7 DM320...
FDA Device Recall #Z-1073-2020 — Class II — December 11, 2019
Recall Summary
| Recall Number | Z-1073-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 11, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Centurion Medical Products Corporation |
| Location | Williamston, MI |
| Product Type | Devices |
| Quantity | N/A |
Product Description
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 DM550 VAD DRIVELINE MANAGEMENT TRAY DM555 LVAD MULTI-DAY DRIVELINE MGMT SIZE M/L DM565 LVAD DRESSING SYSTEM DM575 LVAD MULTI-DAY DRIVELINE MGMT SIZE S DM610 DRIVELINE MANAGEMENT SYSTEM-DAILY DM610 DRIVELINE MANAGEMENT SYSTEM-DAILY DM610 DRIVELINE MANAGEMENT SYSTEM-DAILY DM690 VAD DRIVELINE MANAGEMENT BUNDLE DM710 VAD DAILY DRESSING CHANGE KIT DM720 DAILY LVAD MAINTENANCE KIT DM765 DAILY DRIVELINE MANAGEMENT SYSTEM DM770 WEEKLY DRIVELINE MANAGEMENT SYSTEM DM775 EXTENDED WEAR DRIVELINE MANAGEMENT KIT DM775 EXTENDED WEAR DRIVELINE MANAGEMENT KIT DM805 DAILY LVAD DRIVELINE MANAGEMENT SYSTEM DM870 DAILY MAINTENANCE SYSTEM LVAD DM920 GAUZE DRIVELINE MANAGEMENT KIT DM925 SORBAVIEW DRIVELINE MANAGEMENT KIT DM935 DAILY DRIVELINE MANAGEMENT SYSTEM DM950 HIGH DRAINAGE LVAD TRAY
Reason for Recall
Incomplete seals on the sterile package may compromise the sterility
Distribution Pattern
Nationwide Foreign: GHANA
Lot / Code Information
Product-Lot Code: DM1005 DAILY LVAD MAINTENANCE KIT 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 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 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
Other Recalls from Centurion Medical Products Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1047-2020 | Class II | Centurion- Dressing Change Tray DT10290S CENTR... | Dec 11, 2019 |
| Z-1091-2020 | Class II | Centurion- ENT SNUF3 SNUFFER KIT Y | Dec 11, 2019 |
| Z-1063-2020 | Class II | Centurion-LVAD Kits DM1005 DAILY LVAD MAINTENA... | Dec 11, 2019 |
| Z-1090-2020 | Class II | Centurion- Skin Prep Kits SB1280 SKIN SCRUB KI... | Dec 11, 2019 |
| Z-1058-2020 | Class II | Centurion- Umbilical Trays UVT1045 UMBILICAL A... | Dec 11, 2019 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.