23 September 2013 | News | By BioSpectrum Bureau
Baxter voluntary recalls two lots of its Dual Luer Lock Caps due to presence of loose particulate matter in the packaging
Singapore: Baxter International has initiated a voluntary recall of two lots of its Dual Luer Lock Caps (Product Code 2C6250, Lots 10043 and 10044) because of the presence of loose particulate matter found in the packaging.
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.
There have been no reported complaints associated with this issue, however, embolic events may not be easily attributed to such particulate matter. The root cause has been identified and resolved. The US FDA has designated this as a class I recall.
Baxter's Dual Luer Lock Cap is used as a protective cap on access ports on medical devices such as stopcocks or intra venous (IV) sets when not in use.