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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
See all 13 products in this recall →Related recalls
Same manufacturer · Centurion Medical Products Corporation
See all →- HighCenturion Difficult IV Kit Recalled for False Carboxyhemoglobin Results
FDA (Devices) · 2020-07-15
- HighCenturion ENT Snuffer Kit Recalled for Incomplete Sterile Package Seals
FDA (Devices) · 2020-02-12
- HighCenturion Chest Tube Trays Recalled for Incomplete Package Seals
FDA (Devices) · 2020-02-12
- HighCenturion Medical Products Recalls Sterile Pitcher Kits Due to Seal Defects
FDA (Devices) · 2020-02-12
- HighCenturion Medical Products Recalls Sterile Hyperalimentation and Dressing Change Trays
FDA (Devices) · 2020-02-12
Same hazard · infection
See all →- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
Similar recalls
- HighCenturion Medical Recalls LVAD Kits Due to Incomplete Sterile Package Seals
FDA (Devices) · 2020-02-12
- HighCenturion Universal Line Full Body Drape Kit Recalled for Packaging Defect
FDA (Devices) · 2019-11-13
- HighCenturion Medical Recalls LVAD Kits Due to Incomplete Sterile Seals
FDA (Devices) · 2020-02-12
- CriticalCenturion LVAD Maintenance Kits Recalled for Potential Sterility Failure
FDA (Devices) · 2024-03-06
- HighCenturion Ophthalmic Dressing Kits Recalled for Sterile Packaging Breach
FDA (Devices) · 2017-04-12
- HighCenturion Medical Recalls Post-Operative Ophthalmic Dressing Kits Due to Sterility Concerns
FDA (Devices) · 2017-04-12