Baxter announced a voluntary Class I recall of two lots of its Dual Luer Lock Caps due to the presence of loose particulate matter found in the packaging. The 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.
If particulate matter enters the fluid path from the Luer Lock Caps, it may result in thrombotic and embolic events, including pulmonary embolism, myocardial infarction, and stroke.
The affected products have Lot # 10043 and 10044 with Product Code 2C6250. The cause has been identified and resolved. The affected lots were distributed between June 19–August 20, 2013. The unaffected lots of Product Code 2C6250 are also available for replacement.
Customers are recommended to locate and remove all affected products from their facility. Affected lots should be returned to Baxter for credit by calling (888) 229-0001.
For more information call (888) 229-0001 or visit the FDA safety alert page.