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Baxter issues Class 1 recall of Clearlink Basic Solution Sets with Duovent

By Brian Buntz | September 15, 2022

Baxter logoThe FDA has classified a recall of a Baxter Healthcare product used to deliver hazardous drugs such as chemotherapeutic agents Class 1, indicating that it could cause serious adverse health consequences or death.

The recall covers all lots with product code 2R8403 distributed from October 14, 2020 to June 30, 2022. There are

Baxter announced the recall after receiving 83 customer reports of leaks.

Because the Clearlink Basic Solution Sets with Duovent are used for hazardous drugs, a leak could expose healthcare personnel.

The problem with the affected product lots of the Clearlink Basic Solution Sets could also cause patients to receive insufficient therapy or may lead to the failure of the sterile fluid pathway and infusion with contaminated fluid. In addition, the problem could delay or interrupt therapy and air ingress into the solution set.

There have been no reports of injuries or deaths tied to the product before the recall.

Baxter initially announced an ‘urgent recall’ of the product in August.

In a statement, Baxter noted that it would continue manufacturing and distributing product code 2R8403 owing to a limited supply of non-di(2- ethylhexyl) phthalate (nDEHP) alternatives.

The company provided customers not experiencing leak complications with guidance on how to use the product while monitoring the solution sets for potential problems.

In November 2021, Baxter ramped up its fill-finish capabilities with a $100 million investment in Germany.

A year earlier, the company invested $50 million in a fill-finish plant in Indiana.

About The Author

Brian Buntz

The pharma and biotech editor of WTWH Media, Brian is a veteran journalist with more than 15 years of experience covering an array of life science topics, including clinical trials, drug discovery and development and medical devices. Before coming to WTWH, he served as content director focused on connected devices at Informa. In addition, Brian covered the medical device sector for 10 years at UBM. At Qmed, he overhauled the brand’s news coverage and helped to grow the site’s traffic volume dramatically. He had previously held managing editor roles on two of the company’s medical device technology publications. Connect with him on LinkedIn or email at bbuntz@wtwhmedia.com.

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