Federal regulators have declared a Class I recall for two lots of protective caps used for IV sets after the manufacturer recognized the presence of particular matter in the packaging, which may pose a risk of infection and clotting for patients if it enters the blood stream.
A Baxter Dual Luer Caps recall was announced by the FDA on September 19, due to the potential for particulate matter located in the caps to transfer into IV sets or stopcocks when not in use.
In the event that the particles did contaminate or transfer into the IV lines patients could suffer from pulmonary embolisms, myocardial infarction and even strokes. To date, no injuries have been reported.
The affected Lauer Lock Caps are used as a protective cap on various access ports on medical devices that are not in use such as IV sets and stopcocks.
The recall includes two lots of Dual Luer Caps with product code 2C6250 and lot numbers 10043 and 10044 that were distributed to customers from June 19, 2013 to August 20, 2013.
Baxter International announced that it is cooperating with the FDA and has determined the cause of the problem. The problem has since been resolved.
Class I recalls are considered the most dangerous kind due to the reasonable probability that the use of the product will lead to serious and severe health consequences including death.
The FDA recommends that customers with affected lots immediately stop using the product and contact Baxter Healthcare Center for Service at 1-888-229-0001 to schedule a return for credit or replacement with caps from unaffected lots.