Heparin Coated Thoracic Drainage Catheters Recalled by Atrium
May 15th, 2008 amy
In connection with the massive heparin recall, heparin coated medical devices are now being added to the list of potentially deadly items. Atrium Medical Corporation has announced a recall of selected lots of HYDRAGLIDE Brand Heparin-Coated Thoracic Drainage Catheters, due to the fact that some lots of Atrium heparin-coated Hydraglide Thoracic Catheters were manufactured with heparin 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.
Customers with affected lots are advised to immediately discontinue use of these devices and obtain replacement catheters from Atrium. Atrium will be working with our customers to replace the affected product as soon as possible. If a non-elective procedure requires use of this catheter, we recommend that you do not use the catheter with either a cell saver autotransfusion system or direct autotransfusion chest drainage collection system for cardiopulmonary bypass surgery.
