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U.S. Department of Health and Human Services

Class 2 Device Recall PRE2001US: Prevena Incision Management Customizable System Box (USONLY)

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 Class 2 Device Recall PRE2001US: Prevena Incision Management Customizable System Box (USONLY)see related information
Date Initiated by FirmJanuary 30, 2014
Date PostedMarch 05, 2014
Recall Status1 Terminated 3 on April 06, 2015
Recall NumberZ-1141-2014
Recall Event ID 67454
510(K)NumberK100821 K123878 
Product Classification negative pressure wound therapy Powered suction pump - Product Code OMP
ProductPRE2001US: 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.
Code Information Kit Lot #'s 2367883, 2383868, 2397882, 2410914
Recalling Firm/
Manufacturer		 KCI USA, INC.
12930 IH 10 West
San Antonio TX 78249
For Additional Information Contact
210-515-4108
Manufacturer 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
FDA Determined
Cause 2		Nonconforming Material/Component
ActionKCL 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 Commerce20,850 units total
DistributionUSA Nationwide Distribution
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OMP
510(K)s with Product Code = OMP
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