Centurion Medical Recalls Daily Driveline Kits Due to Sterile Packaging Concerns
Centurion Medical Products Corporation is recalling 3,250 Daily Driveline 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 the sterile barrier is potentially compromised, creating a risk of harm (infection) that has not yet been reported as an injury or illness, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Centurion Medical Products Corporation is recalling 3,250 units of the Daily Driveline Kit (Kit Code: DM940). The recall is due to a potential for the sterile packaging to be compromised. The kits are used for driveline maintenance and securement of lines for the general patient population.
The affected products are identified by Lot # 2019052190 and have an expiration date of 4/30/2021. The 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.
Healthcare providers and patients should stop using the affected kits immediately. The compromised sterile packaging presents a risk of infection if the product is used. Users should contact Centurion Medical Products Corporation for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- DAILY DRIVELINE KIT Kit Code: DM940 - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
- Manufacturer
- Centurion Medical Products Corporation
- Affected units
- 3,250
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 # 2019052190 Exp: 4/30/2021
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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