Edwards Lifesciences LLC, Fem-Flex II Duraflo Treated Femoral Venous Catheter, 8 Fr. x 11.5 cm, REF DIIFEMII008V, Cardiopulmonary bypass tubing.
This recall has been terminated (originally issued September 11, 2008).
- Recall Initiated
- February 25, 2008
- Posted
- September 11, 2008
- Terminated
- September 16, 2008
- Recall Number
- Z-1894-2008
- Quantity
- 10 units
- Firm Location
- West Midvale, UT
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution.
Lot / Code Info
Lot 58458813
Root Cause
Process control
Action Taken
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.