KCI Recalls Prevena Dressing Kits Due to Connector Connection Difficulty
KCI USA is recalling 20,850 Prevena Dressing kits because the tubing connector is difficult to connect to the canister.
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, 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 PRE1055US: Prevena Dressing, 5 Pack (US-ONLY). 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 exudate 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. The affected products were distributed nationwide in the United States.
The affected lot numbers are 2373869, 2375897, 2382870, 2397889, and 2410932. Consumers and healthcare providers should stop using the affected products and contact KCI USA for further instructions.
The recalled product
- Product
- PRE1055US: Prevena Dressing, 5 Pack (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 removing exudate
- 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 (5)
- Kit Lot #'s 2373869
- 2375897
- 2382870
- 2397889
- 2410932
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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