Recall: OriGen Catheters
On 2017-09-12, the FDA announced that OriGen Biomedical is conducting a recall on Catheters due to a possible defect. The recalled products were sold under the brand name(s) OriGen during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 6 medical devices recalls due to potential defect, including insulin delivery device, extension cable and more. Additionally, there have been 1 drug and medical device recalls due to other health hazards as well as 93 food recalls.
Company Contact Information:
Name: OriGen Biomedical
Phone: 1 (512) 474-7278
Do you work for a company involved with this recall? Contact us to learn how you can control data, information and ads shown on this page.
Detailed Recall Information
Regions Where Sold: 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
Product Description: Catheters
Brand Name(s): OriGen
Reason for Recall: Defect
Official Recall Date: 2017-08-22
Note: Although this recall announcement is dated 08/22/2017, it was not published by the FDA until 09/12/2017.
Additional information provided by the FDA.gov:
On August 2, 2017, OriGen Biomedical initiated a nationwide recall for two (2) lots of VV28F Reinforced Dual Lumen ECMO Catheters. These VV28F Reinforced Dual Lumen ECMO Catheters have been found to have the potential for a separation of the clear extension tube from the hub that it is inserted in, which potentially could result in required intervention to prevent permanent impairment/damage. Read More.
More information may be available at FDA.gov
Latest Safety Recalls
Select image for details, including additional styles.
Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.