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May 2008
Company:
New Hampshire Atrium Medical
Product:
HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters
HUDSON, New Hampshire Atrium Medical recalled selected lots of HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters. Limited lots of Atrium heparin-coated Hydraglide Thoracic Catheters were manufactured with he parin found to have been contaminated with oversulfated chondroitin sulfate (OSCS). 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 do not contain high levels of heparin, there still exists a potential exposure of OSCS to the patient.
 
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