KCI Prevena Peel and Place System Kit Recalled for Connector Issues
KCI USA is recalling Prevena Peel and Place System Kits because the male tubing connector is difficult to connect 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific defect is a mechanical difficulty in connecting tubing, which is a functional issue rather than a direct contamination or acute injury hazard, fitting the Moderate severity criteria for a Class II recall without reported serious injuries.
Plain-English summary
KCI USA, INC. is recalling the Prevena Peel and Place System Kit (PRE1001). The recall involves 20,850 units distributed nationwide in the United States. The product 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 negative pressure wound therapy.
The recall was initiated because the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing. This issue affects the specific lot numbers listed in the recall notice, including 2363893, 2367890, 2368876, 2368877, 2379870, 2382869, 2389874, 2397884, 2406889, 2410933, 2411866, 2417879, and 2423890.
Healthcare providers and facilities should stop using the affected units and contact KCI USA for further instructions on the recall process.
The recalled product
- Product
- PRE1001: Prevena Peel and Place System Kit 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 exudates
- 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 (13)
- Kit Lot #'s 2363893
- 2367890
- 2368876
- 2368877
- 2379870
- 2382869
- 2389874
- 2397884
- 2406889
- 2410933
- 2411866
- 2417879
- 2423890
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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