Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1136-2014·Announced 2014-03-12

KCI USA Recalls Prevena Peel and Place System Kits

KCI USA is recalling Prevena Peel and Place System Kits because the tubing connector is difficult to connect 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 source text describes a mechanical difficulty in connecting components without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.

Plain-English summary

KCI USA, INC. is recalling the Prevena Peel and Place System Kit (US-ONLY), product code PRE1001US. The recall involves 20,850 units distributed nationwide in the United States. The affected lots are 2363894, 2365884, 2367866, 2367891, 2367892, 2367893, 2367894, 2367900, 2376873, 2376874, 2376876, 2386885, 2397885, 2397886, 2397887, 2397888, 2398866, 2410934, 2410935, and 2421871.

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 should stop using the affected products and contact KCI USA, INC. for instructions on return or replacement.

The recalled product

Product: PRE1001US: Prevena Peel and Place System Kit (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 environment and…
Manufacturer: KCI USA, INC.
Category: Medical Device — Wound Care
Hazard: mechanical-defect
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 (20)

Kit Lot #'s 2363894
2365884
2367866
2367891
2367892
2367893
2367894
2367900
2376873
2376874
2376876
2386885
2397885
2397886
2397887
2397888
2398866
2410934
2410935
2421871

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 →

Same manufacturer · KCI USA, INC.

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Same hazard · mechanical defect