September 19, 2022

FDA: Class I recall of Baxter Clearlink Basic Solution Set with Duovent

By: Judy Mathias
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Editor's Note

The Food and Drug Administration (FDA) on September 15 identified Baxter Healthcare Corporation’s recall of its ClearLink Basic Solution Set with Duovent as Class I, the most serious.

The recall was initiated because of the risk for leaks that may expose providers and patients to hazardous toxic substances (chemotherapy). The leaks also may allow air into the set or breach the sterile fluid pathway, which would increase the risk of air embolism and contaminated infusions.

To date, there have been 83 complaints, no injuries, and no deaths associated with this issue.

Distribution dates were October 14, 2020, to June 30, 2022.

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