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.
This recall has been terminated (originally issued September 29, 2009).
- Company
- Convatec
- Recall Initiated
- July 13, 2009
- Posted
- September 29, 2009
- Terminated
- October 2, 2009
- Recall Number
- Z-1814-2009
- Quantity
- 764
- Firm Location
- Skillman, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Labeling: the actual manufacturing date (2/2009) and actual expiration date (2/2011) are switched.
Distribution
Nationwide distribution and ConvaTec sales rep in the UK and France.
Lot / Code Info
Product Order # 44650, Lot number 0902102.
Root 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.
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