The Medical Device Business Journal — Medical Device News & Articles | MassDevice

The FDA announced today that the recall of the Clearlink basic solution set with Duovent from Baxter (NYSE:BAX) is Class I, the most serious kind.

Clearkink with Duovent is part of a system for administering drugs and solutions to patients. The majority of the sets are used for the delivery of hazardous drugs (chemotherapy).

Increased customer reports of leaks led Baxter to recall the Clearlink set. As the majority of the devices are used for hazardous drug delivery, leakage could expose people to the drugs. This means healthcare personnel, patients, and others could potentially be exposed to drugs that may be toxic and/or are irritants.

The company distributed 511,728 devices in the U.S. between Oct. 14, 2020, and June 30, 2022. Baxter initiated the recall on Aug. 9, 2022.

Get the full story at our sister site, Drug Delivery Business News.

Filed Under: Drug Pumps, Drug-Device Combinations, Food & Drug Administration (FDA), Recalls, Regulatory/Compliance Tagged With: Baxter, FDA

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