The 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.