www.fdanews.com/articles/175499-cook-medical-broadens-recall-for-beacon-tip-catheter-to-include-more-lots
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Cook Medical Broadens Recall for Beacon Tip Catheter to Include More Lots
February 26, 2016
Cook Medical has stretched its original July 2015 recall for the Beacon Tip Catheter to include more product lots, an FDA press release states. The recall now affects 408,011 catheters in U.S. markets.
The 360-lot recall for single lumen central venous catheters and pressure monitoring sets and trays was over a slew of issues with catheter tip fracture or separation.
According to the release, Cook has added eight catalog numbers and 63 lot numbers to the Class 1 recall.
Beacon tip angiographic catheters are used to inject contrast dye into blood vessels in the heart to prepare it for a cardiac angiogram. — Anisa Jibrell