Baxter’s ClearLink Infusion Set Recall is Class I

The U.S. Food and Drug Administration has identified Baxter’s August 9 recall of its ClearLink Basic Solution Set with Duovent as Class I.
 
511,728 devices were recalled in the U.S., which were distributed between October 14, 2020 and June 30, 2022. The set is used to administer drugs and solutions, the majority of which are used to deliver hazardous drugs (chemotherapy).
 
Baxter recalled the sets due to increased reports of leaks. Because the majority of sets are used to deliver chemotherapy, leakage may expose healthcare personnel, patients, and others to drugs that may be toxic and/or are irritants.
 
The leaks can also let air into the set or breach the sterile fluid pathway, increasing risk of air embolism and contaminated infusions. Patients may suffer delayed or interrupted therapy or may not receive the correct amount of their medication.
 
Thus far, according to FDA, there have been 83 complaints, no injuries, and no deaths linked to the issue.
 
Baxter’s Urgent Medical Device Recall Letter advised customers to monitor impacted solution sets—including during administration set priming and during bedside use—for leaks and stop using them if leaks are experienced.