Centurion Medical Recalls High Drainage LVAD Tray Kits Due to Packaging Concerns
Centurion Medical Products Corporation is recalling 192 High Drainage LVAD Tray Kits because sterile packaging may be compromised.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe (4). While no injuries are explicitly reported, the potential for sterile packaging compromise in a medical device context aligns with the Severe classification for Class II recalls.
Plain-English summary
Centurion Medical Products Corporation is recalling 192 units of the High Drainage LVAD Tray Kit (Code: DM950). The recall is due to a potential for the sterile packaging to be compromised. The product is used for driveline maintenance and securement of the line for the general patient population.
The affected units are identified by Lot # 2019041590 with an expiration date of 6/30/2020. These products were distributed nationwide 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 FDA has classified this as a Class II recall. No specific instructions for consumers are provided in the source text, but patients and healthcare providers should verify the lot number and expiration date of their kits against the recalled information.
The recalled product
- Product
- HIGH DRAINAGE LVAD TRAY Kit Code: DM950 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
- Manufacturer
- Centurion Medical Products Corporation
- Affected units
- 192
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 # 2019041590 Exp: 6/30/2020
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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