Clearkink (drug delivery systems)

2022: Baxter recalls defective chemotherapy drug delivery systems

On September 15, 2022, the recall of Baxter's Clearlink solution kits was announced. The recall refers to Class I, the most serious type of recall.

Clearkink with Duovent technology is part of the system for administering drugs and solutions to patients. Medical facilities use such kits mainly to administer dangerous drugs, such as chemotherapeutic drugs, to patients.

Clearkink (drug delivery systems)

Increased customer reports of leaks led Baxter to withdraw the Clearlink kit, as people could be exposed to dangerous drugs as a result of the leak. Leaks can also cause air to enter the kit or disrupt the sterility of the fluid supply channel. These cases lead to an increased risk of air embolism and infected infusions. The consequence of this can be a delay or interruption of therapy, that is, patients may not receive the required amount of drugs.

Collectively, these problems can lead to serious injury or death, the notice said. Baxter received 83 complaints, but no injuries or deaths related to these issues were reported.

The company distributed 511,728 devices in the United States between October 14, 2020 and June 30, 2022. Baxter began the recall on August 9, 2022. An urgent letter from Baxter about the recall of medical devices instructs users to closely monitor the use of solution injection kits for leaks. If leaks are detected, the use of recalled products should be stopped. Affected products may be returned to Baxter. The company plans to give customers a follow-up notice with additional instructions.

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