FDA Gives Update on Baxter Healthcare’s Recall of Clearlink Basic Solution Sets with Duovent
The FDA has issued an update on Baxter Healthcare’s Aug. 9 recall of its Clearlink Basic Solution Sets with Duovent, deeming it a Class 1 recall because of the risk of serious injury or death.
The agency said the majority of these sets are used to deliver hazardous drugs — specifically, chemotherapy.
The reason for the recall follows increased customer reports of leaks. Leakage could expose healthcare personnel, patients and others to potentially hazardous drugs that may be toxic and/or are irritants.
The FDA said the leaks could also allow air into the set or breach the sterile fluid pathway, increasing the risk of air embolism and contaminated infusions.
The 511,728 affected products were distributed from Oct. 14, 2020, to June 30 of this year. There have been 83 complaints but no reports of injuries or deaths associated with this issue, the FDA said.