Recall Z-2045-2009 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
ConvaTec
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 flu
| Date | Sep 9, 2009 (initiated Jul 29, 2009) |
| Status | Terminated |
| Reason | Labeling: The expiration date does not appear on the product label. |
| Root cause | 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 | 152 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061788 | BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM Boehringer Laboratories, Jul 11, 2006 |