Centurion Driveline Management System 1 Daily Kit Recalled for Packaging Risk
Centurion Medical Products is recalling 6,180 Driveline Management System 1 Daily 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a potential packaging defect without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Centurion Medical Products Corporation is recalling 6,180 units of the Driveline Management System 1 Daily Kit (Code: DT18440A, Lot # 2018110590, Exp: 4/30/2020). The recall was initiated due to a potential for the sterile packaging to be compromised.
The affected kits are used for driveline maintenance and securement of lines for the general patient population. The products were distributed nationwide in the states of AZ, CA, FL, GA, IL, KY, MA, MD, MI, NC, NH, NY, OH, SC, TX, TN, VA, WA, and WI.
Healthcare providers and consumers should stop using the affected kits and contact Centurion Medical Products Corporation for further instructions or a replacement.
The recalled product
- Product
- DRIVELINE MANAGEMENT SYSTEM 1 DAILY Kit Code: DT18440A - Product Usage: Kit is used for Driveline Maintenance and Securement of Line for general patient population.
- Manufacturer
- Centurion Medical Products Corporation
- Affected units
- 6,180
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 # 2018110590 Exp: 4/30/2020
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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