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.
Reported: June 17, 2015 Initiated: May 5, 2015 #Z-1758-2015
Product Description
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.
Reason for Recall
Potential device damage on the strain relief near the hub area, which may result in blood leakage.
Details
- Recalling Firm
- Edwards Lifesciences, LLC
- Units Affected
- 3,360 units.
- Distribution
- 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.
- Location
- Draper, UT
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Edwards Lifesciences, LLC. Units affected: 3,360 units..
Why was this product recalled? ▼
Potential device damage on the strain relief near the hub area, which may result in blood leakage.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 17, 2015. Severity: Moderate. Recall number: Z-1758-2015.
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