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Terminated

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

FDA Recall Z-0318-2007 · Posted 2006-12-29

Recalling FirmEdwards Lifesciences Corporation of Puerto Rico
Recall StatusTerminated
Product CodeFOZ
Date Initiated2006-11-02
Date Terminated2012-02-07
Product Quantity55 units domestically , 80 units internationally and 50 units are in Edwards Lifescience control

Reason for Recall

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

Firm Action

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.

Root Cause

Other

Distribution Pattern

1 Domestic and 1 Foreign

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K992532VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATINGBaxter Healthcare Corp · 2000-06-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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