Atrium Medical Corporation has recalled selected lots of HYDRAGLIDE™ Brand Heparin-Coated Thoracic Drainage Catheters. Limited lots of Atrium heparin-coated Hydraglide Thoracic Catheters were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS). Apparently, the patient risk associated with the presence of OSCS in heparin-coated medical devices is not known at this time. The U.S. Food and Drug Administration has received reports of serious injury and death in patients who have been administered injectable heparin products containing high levels of OSCS.
While Atrium’s HYDRAGLIDE Catheters, according to the company, do not contain high levels of heparin, there still exists a potential exposure of OSCS to the patient. Customers with affected lots are advised to immediately discontinue use of these devices and obtain replacement catheters from Atrium. The company says it will replace the affected product as soon as possible. Atrium says it has not received reports of any OSCS-related adverse events arising from any use of their Hydraglide Thoracic Catheters. The company says a voluntary recall was initiated as a precaution to minimize any future potential risk. The Customer Notification actions were being taken with the knowledge of the U.S. Food and Drug Administration. Physicians and hospital personnel with product-related questions should call the company at 1-800-5-ATRIUM.
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