FDA Device

Edwards Lifesciences VANTEX Central Venous Catheter Set with OLIGON-Model A2720S

Hazard

Lack of Assurance of Sterility-Device packaging was manufactured with an incorrect lid that could compromise the sterility of the product.

What You Should Do

Remedy

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.

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Products

Edwards Lifesciences VANTEX Central Venous Catheter Set with OLIGON-Model A2720S
Brand
Edwards Lifesciences Corporation of Puerto Rico
UPC
Model A2720S Lot Numbers: 946DC131, 946DC239 and 946FC460

Units Affected

55 units domestically , 80 units internationally and 50 units are in Edwards Lifescience control

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