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AngioDynamics recall

This article was originally published in The Gray Sheet

Executive Summary

Firm recalls its Centros self-centering, tunneled hemodialysis access catheters July 10 upon finding that the catheter cuffs were in some cases inadequately attached. AngioDynamics began a limited launch of the catheter in January and has shipped 1,500 units. The defect, reported in less than 1% of products with no adverse outcomes, is believed to be related to an outside manufacturers' production process. The firm expects the cost of the recall to be minimal and to resume shipments in its fiscal third quarter, which begins Dec. 1. Centros is designed with unique curved tips that keep the ports away from vein walls. According to AngioDynamics, the market for chronic dialysis catheters exceeds $150 million
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