Class I Recall Of Abdominal Stent Graft

September 5, 2020

The FDA has announced a Class I recall, the most serious type of recall, of all lots of Endologix Ovation iX Abdominal Stent Graft System manufactured from 2015 to the present, which involves 5,403 such medical devices. The Ovation iX Abdominal Stent Graft System is intended to treat patients with a[...]

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FDA Announces Voluntary Recall Of Two Coronary Catheters

June 27, 2020

The FDA announced on February 20, 2020 that Abbott has voluntarily recalled specific lots of two catheters used in coronary angioplasty procedures: the NC Trek RX Coronary Dilatation Catheter and the NC Traveler Coronary Dilatation Catheter, balloon diameters 4.0mm, 4.5mm and 5.0mm. The recall does [...]

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9.1M Surgical Gowns Recalled

February 13, 2020

On January 21, 2020, “Cardinal Health informed customers of a voluntary recall for the surgical gowns produced by a contract manufacturer after discovering that some gowns were produced in unapproved locations that did not maintain proper environmental conditions as required by law, were not r[...]

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