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U.S. Department of Health and Human Services

Class 3 Device Recall Engenex Wound Cover

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  Class 3 Device Recall Engenex Wound Cover see related information
Date Initiated by Firm July 29, 2009
Date Posted September 09, 2009
Recall Status1 Terminated 3 on October 02, 2009
Recall Number Z-2043-2009
Recall Event ID 52814
510(K)Number K061788  
Product Classification Negative Pressure Wound Therapy Powered Suction Pump - Product Code OMP
Product Engenex Wound Cover; Product Code 446470;
Advanced Negative Pressure Wound Therapy System;
Sterile, Box Contains 10 units.
Boehringer Wound Systems, LLC, Norristown, PA 19404;
Manufactured for: ConvaTec Inc., Skillman, NJ 08558. Negative Pressure Wound Therapy system is intended for the application of negative pressure to wounds to promote wound healing and for the removal of fluids including wound exudates, irrigation fluids, body fluids and infection material.
Code Information Lot number: 0812102; Exp. 12/2010.
Recalling Firm/
200 Headquarters Park Dr
Skillman NJ 08558
For Additional Information Contact Minisha Savani
Manufacturer Reason
for Recall
Labeling: The expiration date does not appear on the product label.
FDA Determined
Cause 2
Labeling design
Action Urgent Product Recall letters dated 7/29/09, were hand delivered to all direct customers by ConvaTec Sales Reps. Customers were asked to return any unused products to their supplier. The letter also stated that a credit would be issued for the product. Customers are to contact Karen Krenta at the firm's Customer Interaction Center, 1-800-422-8811.
Quantity in Commerce 176 units
Distribution 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 and Original Applicant = BOEHRINGER LABORATORIES