FDA-Device2015-06-17Class II
Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System. Packaged sterile and non-pyrogenic in a sealed, peel-type pouch For use in patients undergoing cardiopulmonary bypass.
Edwards Lifesciences, LLC
Hazard
Potential device damage on the strain relief near the hub area, which may result in blood leakage.
Sold states
Nationwide Distribution -- US, including the states of Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia.
Affected count
3,360 units.
Manufactured in
12050 Lone Peak Pkwy, N/A, Draper, UT, United States
Products
Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System. Packaged sterile and non-pyrogenic in a sealed, peel-type pouch For use in patients undergoing cardiopulmonary bypass.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1758-2015Don't want to check this manually?
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