OriGen Biomedical is recalling two lots of its VV28F Reinforced Dual Lumen ECMO Catheters because the clear extension tube may separate from the hub that it is inserted in, which could cause damage or impairment to the patient if there is not immediate intervention. To date, one adverse event related to these recalled products has been reported.
The VV28F Reinforced Dual Lumen ECMO Catheters that fall under the recall include lot number N18487, with the manufacture date of Aug. 14, 2014, and the expiration date of Aug. 30, 2018; and the not number 18487-1, with the manufacture date of April 15, 2015, and the expiration date of April 30, 2019. About 180 units were distributed to medical facilities in the following states: Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Michigan, Missouri, New York, Ohio, Oklahoma, Oregon, Rhode Island, South Dakota, Texas, Tennessee, Washington, and Wisconsin.
The OriGen RDLC catheter is used as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours of less.
OriGen Biomedical is aware of two product failures and has received two complaints related to this problem. “A recurrence of this event could result in serious patient injury,” the company said in a press release.
Any adverse events related to use of these recalled OriGen Biomedical catheters should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice