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.
This recall has been terminated (originally issued September 9, 2009).
- Company
- Convatec
- Recall Initiated
- July 29, 2009
- Posted
- September 9, 2009
- Terminated
- October 2, 2009
- Recall Number
- Z-2043-2009
- Quantity
- 176 units
- Firm Location
- Skillman, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Labeling: The expiration date does not appear on the product label.
Distribution
Nationwide Distribution
Lot / Code Info
Lot number: 0812102; Exp. 12/2010.
Root Cause
Labeling design
Action Taken
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.
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