Edwards Lifesciences Corporation of Puerto Rico Edwards Lifesciences VANTEX Central Venous Catheter Set with OLIGON-Model A2720S Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Edwards Lifesciences VANTEX Central Venous Catheter Set with OLIGON-Model A2720S
Brand
Edwards Lifesciences Corporation of Puerto Rico
Lot Codes / Batch Numbers
Model A2720S Lot Numbers: 946DC131, 946DC239 and 946FC460
Products Sold
Model A2720S Lot Numbers: 946DC131, 946DC239 and 946FC460
Edwards Lifesciences Corporation of Puerto Rico is recalling Edwards Lifesciences VANTEX Central Venous Catheter Set with OLIGON-Model A2720S due to Lack of Assurance of Sterility-Device packaging was manufactured with an incorrect lid that could compromise the sterility of the product.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of Assurance of Sterility-Device packaging was manufactured with an incorrect lid that could compromise the sterility of the product.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026