Recall Z-2044-2009
ConvaTec · initiated July 29, 2009
Product
Engenex Cover Strip; Product Code 446471; Advanced Negative Wound Therapy System; Sterile, Boc 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.
Codes / lots: Lot number: 0808101, Exp 8/2010; lot number 0812102, exp. 12/2010.
Reason for recall
Labeling: The expiration date does not appear on the product label.
FDA-determined 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.
Details
- Recall number
- Z-2044-2009
- Initiated
- July 29, 2009
- Posted by FDA
- September 9, 2009
- Terminated
- October 2, 2009
- Product code
- OMP – Negative Pressure Wound Therapy Powered Suction Pump
- Quantity
- 128 units
- Distribution
- Nationwide Distribution
- Recalling firm
- ConvaTec, Skillman, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2043-2009 | Engenex Wound Cover; Product Code 446470; Advanced Negative Pressure Wound Therapy…Labeling: The expiration date does not appear on the product label. | 07/29/2009Terminated |
| Z-2045-2009 | Engenex Bio-Dome Easy Release Dressing Kit, XL; Product Code 446553; Advanced Negative…Labeling: The expiration date does not appear on the product label. | 07/29/2009Terminated |