Baxter’s August recall of its Clearlink Basic Solution Set with Duovent was labeled a Class I event, the Food and Drug Administration reported in a Thursday notice. The classification indicates the recalled product could cause patient deaths. The agency said it has received 83 complaints about the infusion tubes, but there have been no reports of injuries or deaths.
Because the solution sets are mainly used to deliver drugs such as those used in chemotherapy, leaks can expose patients and healthcare personnel to toxic or hazardous substances, the FDA wrote.
Baxter said in a statement at the time of the recall that customers should monitor the sets for leakage, but if there are no leaks they may continue using the sets. About 500,000 of the Clearlink sets are affected.
Leaks can also disrupt therapy and allow air into the set or sterile fluid pathway, increasing the risk of air entering the blood and of contaminated infusions, the FDA added.
“Patients may suffer delayed or interrupted therapy or may not receive the necessary amount of their medication,” the FDA said. “These issues could lead to serious injury or death.”
Baxter issued its recall on August 9. If leaks are identified, the company wrote, the devices should not be used and it should be returned “for further investigation.” The recall affects 511,728 devices in the U.S., distributed between Oct. 14, 2020, and June 30, the FDA said.