Engenex Bio-Dome Easy Release Dressing Kit, XL; Product Code 446553; Advanced Negative Pressure Wound Therapy System; Sterile, box contains 15 units; Boehringer Wound Systems, LLC, Norristown, PA 19404 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-2045-2009
- Quantity
- 152 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 0709101, Exp 9/2009; lot number 0710101, exp 10/2009.
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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