KCI Recalls Prevena Dressing Kits Due to Connector Connection Issues
KCI USA is recalling 20,850 Prevena Dressing 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. The hazard is a mechanical usability issue (difficulty connecting tubing) rather than a direct biological or chemical hazard, and no injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
KCI USA, INC. is recalling 20,850 units of the PRE1055: Prevena Dressing, 5 Pack. The product is the Prevena Incision Management System, 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 ability to properly assemble the device components.
The affected products were distributed nationwide in the United States. The specific lot numbers involved are 2373868, 2397890, 2407867, 2410931, 2417878, and 2417880. Consumers and healthcare providers should stop using these specific kits and contact KCI USA for further instructions or replacement.
The recalled product
- Product
- PRE1055: Prevena 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 exudates via the ap
- 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 (6)
- Kit Lot #'s 2373868
- 2397890
- 2407867
- 2410931
- 2417878
- 2417880
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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