Date Initiated by Firm | January 30, 2014 |
Date Posted | March 05, 2014 |
Recall Status1 |
Terminated 3 on April 06, 2015 |
Recall Number | Z-1138-2014 |
Recall Event ID |
67454 |
510(K)Number | K100821 K123878 |
Product Classification |
negative pressure wound therapy Powered suction pump - Product Code OMP
|
Product | PRE1055US: Prevena Dressing, 5 Pack (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 2373869, 2375897, 2382870, 2397889, 2410932 |
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 |
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 |
Total Product Life Cycle | TPLC 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) Database | 510(K)s with Product Code = OMP 510(K)s with Product Code = OMP
|