Centurion Medical Recalls LVAD Dressing Kits Due to Sterile Packaging Concerns
Centurion Medical Products Corporation is recalling 1,224 LVAD Dressing System kits because the sterile packaging may be compromised, posing a risk of infection.
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 medical device where sterile packaging may be compromised, creating a risk of harm (infection) for patients, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Centurion Medical Products Corporation is recalling 1,224 units of the LVAD Dressing System with Biopatch (Kit Code: DM700). The recall is due to a potential for the sterile packaging to be compromised. The affected product is identified by Lot # 2019031190 and has an expiration date of 06/30/2020.
The product was distributed nationwide in the United States, specifically in the states of Arizona, California, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, New York, Ohio, South Carolina, Texas, Tennessee, Virginia, Washington, and Wisconsin. The kits are used for the Left Ventricular Assist Device Dressing System for the general patient population.
Consumers and healthcare providers should stop using the affected kits and contact Centurion Medical Products Corporation for further instructions or a replacement.
The recalled product
- Product
- LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used for Left Ventricular Assist Device Dressing System for general patient population.
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Dressing System
- Affected units
- 1,224
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 2019031190 Exp: 06/30/2020
Distribution
Part of a larger recall action
This product is one of 13 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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