Class 3 Device Recall Engenex

• Date Initiated by Firm: July 13, 2009
• Date Posted: September 29, 2009
• Recall Status: Terminated on October 02, 2009
• Recall Number: Z-1814-2009
• Recall Event ID: 52680
• 510(K)Number: K061788
• Product Classification: Wound Therapy Dressing - Product Code OMP
• Product: ConvaTec, Engenex Tunnel Dressing, for use with Engenex Negative Pressure Wound Therapy, (1 x 15 cm) Rx only, Latex Free; Sterile Health Industry Bar Code: H984BWS4464509A. Packaged in boxes of 15 units per box.
• Code Information: Product Order # 44650, Lot number 0902102.
• Recalling Firm/ Manufacturer: ConvaTec; 200 Headquarters Park Dr; Skillman NJ 08558
• For Additional Information Contact: Nimisha Savani; 908-904-2555
• Manufacturer Reason for Recall: Labeling: the actual manufacturing date (2/2009) and actual expiration date (2/2011) are switched.
• FDA Determined Cause: Labeling Change Control
• Action: Recall notification letters were hand delivered on July 13, 2009 to all direct customers (tier 1) by ConvaTec reps. Letters were provided to all direct customers so that they could notify all customers that received the product.
• Quantity in Commerce: 764
• Distribution: Nationwide distribution and ConvaTec sales rep in the UK and France.
• 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