Centurion Medical Recalls Driveline Management Tray Kits Due to Packaging Risk
Centurion Medical Products is recalling 1,900 Driveline Management Tray Kits because 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 with a potential breach in sterile packaging, which poses a risk of harm (infection) to patients, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Centurion Medical Products Corporation is recalling 1,900 units of the Driveline Management Tray Kit (Code: DT17780B). The recall is due to a potential for the sterile packaging to be compromised. The product is used for driveline maintenance and securement of lines for the general patient population.
The affected units are identified by Lot # 2019022690 and have an expiration date of 8/31/2020. These kits were 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.
Healthcare facilities and consumers should stop using the affected kits immediately. Users should contact Centurion Medical Products Corporation for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- DRIVELINE MANAGEMENT TRAY Kit Code: DT17780B - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
- Manufacturer
- Centurion Medical Products Corporation
- Affected units
- 1,900
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 # 2019022690 Exp: 8/31/2020
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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