KCI Recalls Prevena Incision Management System Due to Connector Difficulty
KCI USA is recalling 20,850 units of the Prevena Incision Management System because the tubing connector is difficult to attach to the canister.
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 the hazard involves a mechanical difficulty in connecting components without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
KCI USA, Inc. is recalling 20,850 units of the Prevena Incision Management Customizable System Box (US-ONLY). The recall involves specific kit lot numbers: 2367883, 2383868, 2397882, and 2410914. The product was 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.
Healthcare facilities and consumers who have these specific lot numbers should stop using the product and contact KCI USA, Inc. for further instructions or a replacement.
The recalled product
- Product
- PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) 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…
- 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 (4)
- Kit Lot #'s 2367883
- 2383868
- 2397882
- 2410914
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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