Centurion Medical Recalls LVAD Kits Due to Incomplete Sterile Package Seals
Centurion Medical Products Corporation is recalling various LVAD kits because incomplete seals on the sterile package may compromise sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Centurion Medical Products Corporation is recalling specific lots of Centurion-LVAD Kits, including daily maintenance kits, driveline management systems, and dressing systems. The recall is due to incomplete seals on the sterile package, which may compromise the sterility of the products.
The affected products were distributed nationwide and to Ghana. The source text does not specify the total number of units recalled or report any illnesses or injuries associated with the defect.
Consumers should stop using the affected kits and contact Centurion Medical Products Corporation for further instructions or a replacement.
The recalled product
- 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
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — LVAD Kits
- Hazard
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 54 recalled by Centurion Medical Products Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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