🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: December 11, 2019 Centurion Medical Products Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Centurion Medical Products Corporation
Reason for Recall:
Incomplete seals on the sterile package may compromise the sterility
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1045-2020

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Incomplete seals on the sterile package may compromise the sterility

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