HydraGlide Catheter Recall: Heparin Coating Contaminated
Published: May 15th, 2008 • No Comments
A voluntary recall was issued this week for HydraGlide Thoracic Drainage Catheters which were coated with heparin that may be contaminated with oversulfated chondroitin sulfate. The contaminant is the same chemical that led to the nationwide Baxter heparin recall in February 2008, which resulted in half of the U.S. supply of the blood thinner being removed from the market.
On May 12, 2008, Atrium Medical Corporation initiated the Hydraglide Heparin-Coated Thoracic Drainage Catheter recall after it was discovered that some lots were coated with heparin that was contaminated. The same contaminant has been associated with severe allergic reactions which caused serious injuries for hundreds of people who received high doses of injectable heparin during cardiac surgery or dialysis treatment. According to the FDA, at least 81 deaths over the past year could be related to reactions caused by the heparin contaminant.
Although the heparin coated catheters do not contain high levels of the blood thinner, the recall was initiated as a precautionary measure. Because the drainage catheters carry a potential exposure to oversulfated chondroitin sulfate, customers have been asked to immediately stop using the devices and to obtain replacement catheters from Atrium by calling 1 (800) 5 – ATRIUM.
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