Edwards Lifesciences VANTEX Central Venous Catheter Set with OLIGON-Model A2720S
This recall has been terminated (originally issued December 29, 2006).
- Recall Initiated
- November 2, 2006
- Posted
- December 29, 2006
- Terminated
- February 7, 2012
- Recall Number
- Z-0318-2007
- Quantity
- 55 units domestically , 80 units internationally and 50 units are in Edwards Lifescience control
- Firm Location
- International Industrial Park Anasco, PR
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility-Device packaging was manufactured with an incorrect lid that could compromise the sterility of the product.
Distribution
1 Domestic and 1 Foreign
Lot / Code Info
Model A2720S Lot Numbers: 946DC131, 946DC239 and 946FC460
Root Cause
Other
Action Taken
Edwards initiated the recall in the US by sending a voicemail on November 2, 2006, to their sale representative requesting of all unused product from one domestic customer. The Sale representative was provided with a recall letter for the cutomer to facilitate notification. Edwards requested that either the customer or the Sale Representative provide written verification of stock and identify any unused product to be returned . This will allow Edwards to track the effectiveness of this recall. Their Eurpoe operations initiated a similar recall plan in Europe on November 2, 2006.