December 12, 2016

FDA: Class I recall of Centurion Convenience Kits with Multi-Med Single Lumen Catheters

By: Judy Mathias
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Editor's Note

The Food and Drug Administration (FDA) on December 9 categorized the recall by Centurion Medical Products (Williamston, Michigan) of its Centurion Convenience Kits containing Multi-Med Single Lumen Catheters as Class I, the most serious.

There may be excess material at the tip of the catheters from the manufacturing process. The material may separate from the catheter during use and enter the patient’s bloodstream, which could result in blood clots, embolism of the material to vital organs, or death.

The Kits were distributed between May 23 and October 18, 2016.

FDA3

Excess material may separate from catheter during use and enter patient's bloodstream, resulting in serious adverse health consequences such as blood clots, embolism of the excess material to vital organs, or death.

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