WASHINGTON—Arrow International Inc. has recalled the Arrow NextStep Antegrade Chronic Hemodialysis Catheters due to reports of breakage and/or separation of the stylet, according to an Aug 3 notice from the U.S. Food and Drug Administration (FDA).
These products were distributed to medical facilities and physicians in California, Delaware, Florida, Michigan, North Carolina, and Tennessee. The affected products were manufactured between April 14, 2011, and May 9, 2011.
Click HERE to review the FDA notice and access the production and lot numbers.
The Arrow NextStep Antegrade Catheter is indicated for use in adult patients for attaining long-term vascular access for hemodialysis and apheresis. Chronic hemodialysis catheters are typically placed into a large vein in the patient's neck.
“Customers should check their stock, cease use and distribution, and quarantine all affected product,” according to the FDA.
