Heparin alert hits device makers
This article was originally published in The Gray Sheet
Executive Summary
FDA sends a letter April 8 to 82 medical device manufacturers urging them to test any products containing heparin for contamination. Baxter initiated a recall in January for contaminated heparin that came from China. FDA reminds device makers to submit adverse event reports or issue a recall if needed. Aside from heparin lock flush solutions like Baxter's Hep-Lock, which has already been the subject of a recall, devices that incorporate the drug include certain vascular grafts, such as W.L Gore's Viabahn endoprostheis with heparin bioactive surface, and coated central venous oximetry probes, such as Hospira's Opticath. Other potentially affected products, according to FDA, include some stents; certain oxygenators, filters, reservoirs and cannulae used in cardiopulmonary bypass; certain vascular access and thermodilution catheters; lab tests using heparin-containing reagents; and certain arterial blood gas syringes and blood collection tubes