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FDA recalls hemodialysis blood tubing set

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The FDA has recalled two part numbers of the CombiSet True Flow Series Hemodialysis Blood Tubing Set due to the possibility of arterial line kinking. Kinking can cause red blood cell destruction, resulting in serious injury or death.

The part numbers affected by the recall are 03-2695-9, which was distributed between August 2010 and November 2010 and 03-2795-7, distributed between August 2009 and November 2010. The products were manufactured between June 11, 2010 and October 17, 2010.

The CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors for use with the Blood Volume Monitor is manufactured by Fresenius Medical Care North America. The company sent an “urgent recall” letter to customers on November 19, 2010 to instruct them to check their stock for affected lots. Any customers in possession of affected lots were instructed to discontinue use and return the affected lots to the company.

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