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

PRE2001US: Prevena Incision Management Customizable System recalled

KCI USA is recalling PRE2001US: Prevena Incision Management Customizable System Box (Us-only), 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 #'s 2367883, 2383868, 2397882, 2410914

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-1141-2014
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
Device type: Surgical Instruments

Timeline

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

PRE2001US: Prevena Incision Management Customizable System Box (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 exudates via the application of negative pressure wound therapy.

Where it was distributed

USA Nationwide Distribution

Nationwide

Questions about this recall

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 #'s 2367883, 2383868, 2397882, 2410914

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

Other products in this recall event

7 other products · FDA event 67454

This product is part of a recall event; the main page for the event is PRE1001US: Prevena Peel and Place System Kit (Us-only) recalled.

Reported	Class	Recall	Company	Reason	Where
12 Mar 2014	CLASS II	PRE1001US: Prevena Peel and Place System Kit (Us-only) recalled	KCI USA	Other	Nationwide
12 Mar 2014	CLASS II	PRE1055: Prevena Dressing recalled by Kci Usa	KCI USA	Other	Nationwide
12 Mar 2014	CLASS II	PRE2055US: Prevena Customizable Dressing (Us-only) recalled by Kci Usa	KCI USA	Other	Nationwide
12 Mar 2014	CLASS II	PRE2001: Prevena Incision Management Customizable System recalled	KCI USA	Other	Nationwide
12 Mar 2014	CLASS II	PRE2055: Prevena Customizable Dressing recalled by Kci Usa	KCI USA	Other	Nationwide
12 Mar 2014	CLASS II	PRE1001: Prevena Peel and Place System Kit recalled by Kci Usa	KCI USA	Other	Nationwide
12 Mar 2014	CLASS II	PRE1055US: Prevena Dressing (Us-only) recalled by Kci Usa	KCI USA	Other	Nationwide

More recalls from KCI USA

All 18

Reported	Class	Recall	Company	Reason	Where
26 Feb 2025Device	CLASS II	3M Prevena Plus 125 Therapy Unit and System Kits recalled by Kci Usa	KCI USA	Packaging Defects	Nationwide
26 Feb 2025Device	CLASS II	3M V.A.C. VIA Negative Pressure Wound Therapy System recalled by Kci Usa	KCI USA	Packaging Defects	Nationwide
15 Jul 2020Device	CLASS II	Activ.A.C Therapy System recalled by Kci Usa	KCI USA	Other	Nationwide
7 Jun 2017Device	CLASS II	Canister (with Gel) for InfoV.A.C recalled by Kci Usa	KCI USA	Sterility	Nationwide
13 Jan 2016Device	CLASS II	ActiV.A.C. Canister (with Gel) recalled by Kci Usa	KCI USA	Sterility	TX

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14 Oct 2026Device	CLASS II	Gyn Laparoscopy Pack kits recalled by Avid Medical	Avid Medical	Other	Nationwide