Z-1139-2014Class II

PRE2001: Prevena Incision Management Customizable System Box

Name: Z-1139-2014 PRE2001: Prevena Incision Management Customizable System Box
Creator: Kci USA, Inc.
Published: 2014-01-30
License: https://open.fda.gov/license/

KCI USA, Inc. / initiated 2014-01-30 / Terminated / root cause: manufacturing process

FDA source

KCI USA, INC. began a recall of PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena Incision Management System is intended to manage the environment of... on 2014-01-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1139-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-30
Posted: 2014-03-05
Terminated: 2015-04-06
Recalling firm: KCI USA, Inc.
Product: PRE2001: Prevena Incision Management Customizable System Box 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.
Product code: OMP Negative Pressure Wound Therapy Powered Suction Pump
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
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: KCL sent an Urgent Voluntary Medical Device Correction letter dated February 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to locate, quarantine and return the affected device. For a replacement of the affected product and questions customers were instructed to contact KCL Customer Technical Support at 1-800-275-4524. A Product Reconciliation Form is attached to be completed and returned.
Quantity in commerce: 20,850 units total
Distribution: USA Nationwide Distribution
Product codes and lots: Kit Lot #'s 2383867, 2397883

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1139-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1135-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-12	2014-03-04
Z-1136-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-12	2014-03-04
Z-1137-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-12	2014-03-04
Z-1138-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-12	2014-03-04
Z-1139-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-12	2014-03-04
Z-1140-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-12	2014-03-04
Z-1141-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-12	2014-03-04
Z-1142-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-12	2014-03-04

Product code OMP

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)