OriGen Biomedical Issues Nationwide Recall of OriGen VV28F Reinforced Dual Lumen ECMO Catheters
On August 2, 2017, OriGen Biomedical initiated a recall for two (2) lots of VV28F Reinforced Dual Lumen ECMO Catheters.
Customers who have received product from either of these lots of VV28F Reinforced Dual Lumen ECMO Catheters should return any product that they currently have to OriGen Biomedical. See the recall notice for specific product lot numbers and decriptions.
The OriGen RDLC catheter is indicated for use 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 or less (USA) or less than 29 days (rest of world).
OriGen Biomedical voluntarily recalled OriGen VV28F Reinforced Dual Lumen ECMO Catheters Lot N18487 and N18487-1 after becoming aware of a reported adverse event. OriGen Biomedical has notified the FDA of this action.OriGen Biomedical is aware of two (2) product failures and has received a complaint associated with each of the two (2) product failures. A recurrence of this event could result in serious patient injury.
OriGen Biomedical is notifying distributors and user facilities by e-mail and is arranging for return of all recalled product.
Users within the USA may report adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online or by phone.
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