Recall Z-1814-2009 ยท OMP Negative Pressure Wound Therapy Powered Suction Pump
ConvaTec
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.
| Date | Sep 29, 2009 (initiated Jul 13, 2009) |
| Status | Terminated |
| Reason | Labeling: the actual manufacturing date (2/2009) and actual expiration date (2/2011) are switched. |
| Root 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 | 764 |
| Distribution | Nationwide distribution and ConvaTec sales rep in the UK and France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061788 | BOEHRINGER LABORATORIES SUCTION PUMP SYSTEM Boehringer Laboratories, Jul 11, 2006 |