After the discovery of the loose particulate matter within packaging, Baxter International Inc. announced it has initiated a voluntary recall of two lots of its Dual Luer Lock Caps (Product Code 2C6250, Lots 10043 and 10044).
Baxter’s Dual Luer Lock Cap is used as a protective cap on access ports on medical devices such as stopcocks or IV sets when not in use. Affected lots were distributed to customers between June 19, 2013, and August 20, 2013.
The FDA’s and the company’s concern is that particulate matter entering the fluid path from the Luer Lock Caps may result in thrombotic and embolic events, including: pulmonary embolism, myocardial infarction and stroke. Although there have been no known reported complaints associated with this issue, it is important to bear in mind that embolic events may not be easily attributed to such particulate matter. The root cause of the contamination has been identified and resolved. FDA has designated this as a Class I recall.
The FDA recommends that affected customers should immediately discontinue the use or distribution of the recalled lots.
From a strictly financial standpoint, the company claims that the recall is not material.