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AngioDynamics issues product recall pending FDA review
www.bizjournals.com AngioDynamics, Inc. is voluntarily recalling all hospital inventory of Centros, a catheter used in dialysis.
The Queensbury, N.Y.-based medical device manufacturer said it became aware that the catheter cuff, a component intended to anchor the catheter in the tissue just below the skin, was inadequately attached to the catheter in a few instances.
AngioDynamics (Nasdaq: ANGO) has identified the cause of the cuff problem and believes it is related to an outside manufacturer's production process. Pending a review by the U.S. Food and Drug Administration, shipments of Centros are expected to resume during the company's fiscal third quarter, which begins Dec. 1.
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