The presence of loose particulate matter found in the packaging of Dual Luer Lock Caps prompted Baxter International Inc. to announce a voluntary recall on September 19, 2013. The FDA has designated this as a Class I Recall, the most serious class of recalls, which applies to dangerous or defective products that pose a reasonable probability of causing serious health problems or death.
In this case, the FDA warns consumers that particulate matter of this type entering the bloodstream can cause serious health risks, such as pulmonary embolism, myocardial infarction, and stroke. These medical events can result in permanent physical and/or mental disability, or even death. In patients whose cardiovascular function is already be impaired due to trauma, disease, or recovery from major surgery, the risks may be even more severe. Additionally, because complications after these events are common, it may initially be difficult to identify particulate matter as the underlying cause of adverse events.
Baxter’s Dual Luer Lock Caps are protective caps for medical device access ports and are used on stopcocks or IV sets when these devices are not in use. The timeframe for distribution of the affected lots is between June 19, 2013, and August 20, 2013. The affected lots are Lots 10043 and 10044, Product Code 2C6250.
We encourage patients and loved ones who have been affected by Baxter’s Dual Luer Lock Caps or by contamination of other intravenous devices with particulate matter to contact us for a free case evaluation at www.andrewsthornton.com or toll free at 1-800-644-1734.