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VV13F Reinforced Dual Lumen ECMO Catheters by OriGen Biomedical: Recall - Potential for Separation of Tube from Hub
AUDIENCE: Risk Manager, Critical Care Medicine, Pediatrics
ISSUE: OriGen Biomedical initiated a nationwide recall for one lot (lot N18549, expiration 09/2018) of 51 VV13F Reinforced Dual Lumen ECMO Catheters. These VV13F Reinforced Dual Lumen ECMO Catheters have been found to have the potential for a separation of the clear extension tube from the hub in which it is inserted, which potentially could result in required intervention to prevent permanent impairment/damage. OriGen Biomedical is aware of one product failure and has received a complaint associated with the problem. This serious adverse event resulted in a serious patient injury.
BACKGROUND: The OriGen VV13F Reinforced Dual Lumen ECMO Catheters are indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less in Neonatal Intensive Care and Pediatric Intensive Care ECMO centers.
RECOMMENDATION: Customers who have lot N18549 of VV13F Reinforced Dual Lumen ECMO Catheters should return any product that they currently have to OriGen Biomedical.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including links to the Press Release at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm443025.htm
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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