KCI USA Recalls Prevena Customizable Dressing 5-Pack Due to Connector Issue
KCI USA is recalling 20,850 units of the Prevena Customizable Dressing 5-Pack because the male connector on the tubing is difficult to connect to the female connector on the canister tubing.
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. The hazard is a mechanical difficulty in connecting components, which poses a risk of improper use but does not involve a high-risk pathogen or reported serious injury, fitting the criteria for a moderate severity recall.
Plain-English summary
KCI USA, INC. is recalling 20,850 units of the PRE2055: Prevena Customizable Dressing 5-Pack. The product is distributed nationwide in the United States. The specific lot number for the recalled items is 2410919.
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 exudate via negative pressure wound therapy.
Consumers and healthcare facilities should stop using the affected product and contact KCI USA, INC. for further instructions or a replacement.
The recalled product
- Product
- PRE2055: Prevena Customizable Dressing 5-Pack 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 removing…
- Manufacturer
- KCI USA, INC.
- Category
- Medical Device — Wound Care
- 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 (1)
- Kit Lot # 2410919
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.
See all 8 products in this recall →Related recalls
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