Baxter International has issued an Urgent Medical Device Recall of Clearlink Solution Set 2R8403 due to an increase in customer reports of leaks. The affected product was distributed to customers beginning on Oct. 14, 2020, in the United States.
While there have been no reports of serious injury related to this issue, Clearlink Solution Sets are commonly used for the delivery of hazardous drugs. A leaking solution set could result in healthcare personnel, patients and others being exposed to potentially hazardous, toxic, or irritant substances. Additional potential hazards may include insufficient therapy, breach of the sterile fluid pathway and infusion of contaminated fluid, delay or interruption of therapy and air ingress into the solution set.
Due to the limited supply of non-di(2- ethylhexyl) phthalate (nDEHP) alternatives, product code 2R8403 will continue to be manufactured and distributed. nDEHP alternatives will be available in limited quantities and a DEHP alternative is available if clinically acceptable. Additionally, Baxter’s infusion pumps can only be used with the company’s proprietary IV sets. Therefore, customers who are not experiencing leak complications should continue to use Clearlink Solution Sets according to the guidance provided in Baxter’s Urgent Medical Device Recall notification, while monitoring the use of impacted solution sets closely for issues (including during priming of the administration set and during bedside use).