Recall Z-1814-2009
ConvaTec · initiated July 13, 2009
Product
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.
Codes / lots: Product Order # 44650, Lot number 0902102.
Reason for recall
Labeling: the actual manufacturing date (2/2009) and actual expiration date (2/2011) are switched.
FDA-determined cause: Labeling Change Control
Action taken
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.
Details
- Recall number
- Z-1814-2009
- Initiated
- July 13, 2009
- Posted by FDA
- September 29, 2009
- Terminated
- October 2, 2009
- Product code
- OMP – Negative Pressure Wound Therapy Powered Suction Pump
- Quantity
- 764
- Distribution
- Nationwide distribution and ConvaTec sales rep in the UK and France.
- Recalling firm
- ConvaTec, Skillman, NJ