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Terminated

Edwards Lifesciences LLC, Fem-Flex II Duraflo Treated Femoral Venous Catheter, 8 Fr. x 11.5 cm, REF DIIFEMII008V, Cardiopulmonary bypass tubing.

FDA Recall Z-1894-2008 · Posted 2008-09-11

Recalling FirmEdwards Lifesciences Research Medical, Inc.
Recall StatusTerminated
Product CodeDWF
Date Initiated2008-02-25
Date Terminated2008-09-16
Product Quantity10 units

Reason for Recall

Femoral Venous Cannula was color coded as an arterial cannula. This problem could result in a minor delay in the procedure. In the worst case, this product could be connected incorrectly during bypass, which would result in a more significant delay and has the potential to result in a permanent injury.

Firm Action

Consignees were notified by Edwards Lifesciences sales representatives and a Product Recall letter dated 2/22/08. Users were instructed to check their inventory for any affected product and to return all unused product to the recalling firm. Users were also requested to return a recall response form indicating the quantity of affected product.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K033464EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAEEdwards Lifesciences, LLC · 2004-06-22K891576FEM-FLEX FEMORAL ACCESS CANNULATION SETResearch Medical, Inc. · 1989-10-12

Official Source

View FDA Recall →

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

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