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Embolism May Be Caused By Malfunctioning Buretrol Delivery Systems

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The U.S. Food and Drug Administration (FDA) has changed the level of a September 7, 2012, recall of four buretrol solution sets manufactured by Baxter Healthcare (Deerfield, Illinois) to Class I, due to the possibility of malfunction which could cause a patient’s death. The company has also issued an urgent recall notice to its customers of the possible malfunction. Class I recalls apply to products which have a "reasonable risk of serious adverse events or death with use."

MedPage Today, November 10, 2012, by Cole Petrochko, noted both the Interlink System Buretrol Solution Set and the Clearlink System Buretrol Solution set possess a ball-type valve that could allow air to enter the product’s tubing along with fluid which could cause an air embolism and subsequent death to a patient using the solution set.

All lots of the above-mentioned solution sets with 150 ml burettes labeled with or without DEHP are affected by the recall. Sets with product codes 2C7519, 2H7519, 2C8819 and 2H8819 are recalled. Recalled solution sets were manufactured from April 30, 2003 to July 26, 2012 and distributed from May 1, 2003 to August 16, 2012.