Fresenius Medical CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors - Class I Recall
MedSun: Newsletter #57, February 2011

FDA MedWatch Safety Alert

The hemodialysis blood tubing sets may develop kinking of the arterial line. Kinking can cause the destruction of red blood cells which may result in serious injury and/or death. Customers were instructed to check their stock immediately to determine if they had any of the affected lots. If they did, customers were instructed to immediately discontinue using the affected lots and place the products in a secure and separate area for return to the company.

Additional Information:

FDA MedWatch Safety Alert. Fresenius Medical Care North America, CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors for Use with the Blood Volume Monitor. January 20, 2011.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm240547.htm


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