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Terminated

Edwards Lifesciences Vantex Central Venous Catheter Kit with Oligon, Ref/model #: 3K20C1827, Rx only, Edwards Lifesciences LLC, Irvine, CA 96214-5686 USA

FDA Recall Z-0272-04 · Posted 2003-12-24

Recalling FirmEdwards Lifesciences Corporation of Puerto Rico
Recall StatusTerminated
Product CodeFOZ
Date Initiated2003-10-08
Date Terminated2004-02-09
Product Quantity315 units

Reason for Recall

Lot is being recalled because some of the kits contain an incorrect guidewire.

Firm Action

Customers were contacted by their Edwards Sales Representatives on 10/8/03. The Sales Representatives requested that all units be returned.

Root Cause

Other

Distribution Pattern

Distribution was to hospitals (2) in MD and DC.

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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