Baxter recalled 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. Embolic events may not be easily attributed to such particulate matter. The root cause of the particulate matter contamination has been identified and resolved.
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. Non-affected lot numbers can continue to be used according to the instructions for use.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication