PRE1001: Prevena Peel and Place System Kit 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.
FDA Recall Z-1135-2014 · Posted 2014-03-05
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Recalling FirmKCI USA, INC.
Recall StatusTerminated
Product CodeOMP
Date Initiated2014-01-30
Date Terminated2015-04-06
Product Quantity20,850 units total
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
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
USA Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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