Recall Z-1135-2014 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
KCI USA, INC.
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.
| Date | Mar 5, 2014 (initiated Jan 30, 2014) |
| Status | Terminated |
| Reason | 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 | 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 | 20,850 units total |
| Distribution | USA Nationwide Distribution |
| FDA record | Open on fda.gov |