CLASS II Device recall · Reported 12 Mar 2014 · FDA Enforcement Report

PRE2055: Prevena Customizable Dressing recalled by Kci Usa

Kci Usa is recalling PRE2055: Prevena Customizable Dressing, distributed nationwide in the US. The recall was initiated on 30 Jan 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesKit Lot # 2410919
Quantity recalled20,850 units total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1140-2014
FDA event ID
67454
Recalling firm
Kci Usa, San Antonio, TX
Classification
Class II
Status
Terminated
Recall initiated
30 Jan 2014
FDA classified
4 Mar 2014
Reported
12 Mar 2014
Type
Voluntary: Firm initiated
Customers notified by
Visit
Reason category
Other Reasons

Timeline

30 Jan 2014Recall initiated by company
4 Mar 2014Classified by FDA+33 days
12 Mar 2014Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing

Product as listed by the FDA

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 exudates via the application of negative pressure wound therapy.

Where it was distributed

USA Nationwide Distribution

Nationwide

Questions about this recall

Is PRE2055: Prevena Customizable Dressing recalled?

Yes. Kci Usa recalled PRE2055: Prevena Customizable Dressing on 30 Jan 2014. The recall is Class II and its status is Terminated. Recall number Z-1140-2014.

Why was it recalled?

Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing

Which lots are affected?

Kit Lot # 2410919

Where was it sold?

USA Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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