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Home > Recalled Products > Medical Devices > Defect > OriGen Catheters

Recall: OriGen Catheters

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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.

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OriGen Biomedical, Logo
Note: Images may not be available for every version. Please review the detailed description below.

Company Contact Information:

Name: OriGen Biomedical
Website: www.origen.com
Phone: 1 (512) 474-7278

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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.



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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
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Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.

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