Thursday, April 16, 2015

OriGen Biomedical Issues Nationwide Recall of OriGen VV13F Reinforced Dual Lumen ECMO Catheters

You are subscribed to Recalls, Market Withdrawals and Safety Alerts for U.S. Food & Drug Administration (FDA).

This information has recently been updated and is now available.

 

04/15/2015 07:49 PM EDT

On March 30, 2015, OriGen Biomedical initiated a nationwide recall for one lot of 51 VV13F Reinforced Dual Lumen ECMO Catheters. These VV13F 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.

. For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.


This email was sent to filter@clubhouseb.com using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 Powered by GovDelivery

No comments:

Post a Comment