all lots of HydroFinity Hydrophilic Guidewires, produced by NDC and distributed by Covidien, are recalled due to outer jack damage
San Diego, CA (PRWEB) June 23, 2014
AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Hydrophilic Guidewires.
The FDA announced on June 20, that all lots of HydroFinity Hydrophilic Guidewires, produced by NDC and distributed by Covidien, are recalled due to outer jack damage. The HydroFinity Guidewire is a nitinol-core, polymer-jacketed guidewire with a hydrophilic coating used in catheter placement and other procedures to treat vascular diseases.
FDA’s reason for the recall is based on two reports of the outer polymer jacket to the core wire being damaged when the guidewire was withdrawn rapidly through certain delivery catheters and ten cases where the product was less severely damaged during use. This incidence may cause embolization of polymer, and can lead to vessel occlusion or damage that may need surgical intervention to resolve, as happened in one of the cases.
Taking into consideration the latest developments, AttorneyOne.com monitor daily and update the website providing accurate information on all relevant FDA safety alerts. Sean Burke, director of Media Relations at AttorneyOne.com, adds “we are determined to keep an eye on FDA announcements concerning Hydrophilic Guidewires and inform the public. For that reason", he continues, "our focus should squarely fall on investigating these safety alerts and getting the word out.”
As the FDA informs “Covidien alerted customers by letter on June 3, 2014 and is recalling all product.” And the Agency adds “Unused product should be returned to Covidien.”
AttorneyOne.com has further information on Hydrophilic Guidewires at the website including latest major drug and medical products law news.
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