KCI Recalls Prevena Incision Management System Kits Due to Connector Issues
KCI USA is recalling Prevena Incision Management System kits because the male tubing connector is difficult to attach to the female canister connector.
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. The hazard is a mechanical difficulty in connecting components, which is a functional defect rather than a high-risk pathogen or structural failure causing immediate severe injury.
Plain-English summary
KCI USA, INC. is recalling 20,850 units of the Prevena Incision Management Customizable System Box (PRE2001). The recall covers kits with Lot #s 2383867 and 2397883 that were distributed nationwide in the United States.
The recall was initiated because the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing. The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
The source text does not specify specific instructions for consumers or healthcare providers regarding the next steps for these units.
The recalled product
- Product
- PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and r
- Manufacturer
- KCI USA, INC.
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 20,850
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 (2)
- Kit Lot #'s 2383867
- 2397883
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by KCI USA, INC. 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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