| Subject: | Atrium Initiates Voluntary Recall Regarding HYDRAGLIDE™ Brand Heparin-Coated Thoracic Drainage Catheters |
| Category: | Food and Drug Administration (FDA)
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| Published: | Fri, 16 May 2008 - 10:00 am |
| Atrium Medical Corporation has announced that it is initiating a voluntary and precautionary recall of selected lots of HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters. Limited lots of Atrium heparin-coated HYDRAGLIDE Thoracic Catheters manufactured with heparin were found to have been contaminated with oversulfated chondroitin sulfate (OSCS). While the patient risk associated with the presence of OSCS in heparin-coated medical devices is not known at this time, the FDA has... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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