The Recall Desk
ModerateFDA (Devices)·Z-2170-2019·Announced 2019-08-14

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.

What this means for you

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.
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

Distributed nationwide across the United States.

The notice also names 19 states specifically:

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 →