Device maker, Baxter International Inc. has initiated a recall of two lots of its Dual Luer Lock Caps over the presence of loose particulate matter that was detected in the packaging, the U.S. Food and Drug Administration (FDA) announced.
The FDA deemed the recall a Class I, which means that this recall involves a situation in which there is a reasonable probability that the use of, or exposure to, a violative product—in this case, the recalled Dual Luer Lock Caps—will cause serious adverse health consequences or death.
Particulate matter entering the fluid path from the Luer Lock Caps may result in serious thrombotic and embolic events. This includes pulmonary embolism, myocardial infarction, and stroke. To date, no reports of complaints have been received associated with this issue; however, although the root cause of the problem has been identified and resolved, embolic events may not be easily attributed to particulate matter.
Baxter’s Dual Luer Lock Cap is used as a protective cap on access ports on medical devices such as stopcocks or IV sets that are not in use.
The Product Code on the recalled components is 2C6250 and the Lot Numbers involved are 10043 and 10044.
Customers are advised against using the recalled products and should locate and remove all affected product from their facilities. Affected lots were distributed to customers between June 19, 2013 and August 20, 2013. Affected lots should be returned to Baxter for credit by contacting Baxter Healthcare Center for Service, toll-free, at 1.888.229.0001 between 7:00 a.m. and 6:00 p.m., Central Time.
Unaffected lots of product code 2C6250 are available for replacement and non-affected lot numbers can continue to be used according to the instructions for use.
Adverse reactions or quality problems can be reported to the FDA at http://www.fda.gov/Safety/medwatch/howtoreport/default.htm.