On August 17, 2018, OriGen Biomedical has initiated a voluntary nationwide recall of OriGen RDLC ECMO catheters. The product has been found to have certain deficiencies listed on the full notice, which could potentially increase recirculation. There is no related recall. The following products have been recalled**: Product Name: OriGen Biomedical RDLC ECMO Catheters
**This listing of lots has been expanded to include lots which have expired and lots which have already been recovered under a prior recall. Please check stocks carefully.
Customers who have products listed below should return these products to OriGen.
Recalled Product was manufactured from March 2015 through Sept 2017 and distributed
from March 2015 through March 2018.
OriGen Biomedical is notifying its distributors and customers by email and is arranging for return
of all recalled products. OriGen Biomedical distributed products to physicians and distributors in
the United States and Internationally.
Consumers with questions may contact the company via telephone at 1-800 233 9014 between the
hours of 08:00 and 16:30 (CDT). Customers outside the USA may contact OriGen at
+1.512.474.7278. Customers may also contact the company via e-mail at email@example.com. We
appreciate your immediate attention to this and value your continued understanding.
Please note that no injury or adverse events have been reported in any of the devices included in this recall.
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, by regular mail or by fax.
• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-
332-1088 to request a reporting form, then complete and return to the address on the preaddressed
form, or submit by fax to 1-800-FDA-0178
***Updated on September 20, 2018.
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