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U.S. Department of Health and Human Services

Class 2 Device Recall CenturionLVAD Kits

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  Class 2 Device Recall CenturionLVAD Kits see related information
Date Initiated by Firm December 11, 2019
Create Date February 05, 2020
Recall Status1 Terminated 3 on September 04, 2020
Recall Number Z-1063-2020
Recall Event ID 84530
Product Classification Dressing change tray - Product Code OXQ
Product 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 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
Code Information Lot Numbers:  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 
Recalling Firm/
Manufacturer		 Centurion Medical Products Corporation
100 Centurion Way
Williamston MI 48895-9086
For Additional Information Contact SAME
517-546-5400
Manufacturer Reason
for Recall		 Incomplete seals on the sterile package may compromise the sterility
FDA Determined
Cause 2		 Packaging process control
Action Centurion issued a notification emailed to Medline Industries, Centurion's parent company. Centurion issued mailing letters via First Class Mail beginning on 12/12/2019, letter states reason for recall, health risk and action to take: Please identify all inventory that you have within your possession and segregate it in a location where it cannot be accessed for use. 2) If you have transferred possession of this product to another individual, to another department or to another location in your organization, you are required by FDA regulations to notify them of this recall communication. Please ask that any affected product be returned to you for collection. 3) Affected product is not to be returned to Centurion, and should be destroyed/discarded. Document the destruction of all product on the enclosed accountability record. 4) Please complete the enclosed accountability record, whether or not you have product, and fax or email at your earliest convenience to the attention of Lisa Carpenter, Director of Quality Assurance Centurion Medical Products Corporation, (517) 546-5400 Ext.1122.
Distribution Nationwide Foreign: GHANA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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