FDA: CombiSet Hemodialysis Blood Tubing Set Recalled

Tubing set can develop kinking of the arterial line that may result in serious injury and/or death

MONDAY, Jan. 24 (HealthDay News) -- The U.S. Food and Drug Administration and Fresenius Medical Care North America have notified health care providers of a class 1 recall of CombiSet True Flow Series hemodialysis blood tubing sets with priming set and transducer protectors for use with a blood volume monitor, as the hemodialysis blood tubing set can develop kinking of the arterial line that may result in serious injury and/or death.

The CombiSet hemodialysis blood tubing set can be used with conventional and high flux negative pressure hemodialyzer equipment; it is intended only for single use. The recall was issued because kinking of the arterial line may cause the destruction of red blood cells, which can result in an increased risk for serious injury and/or death.

The recall affects only part number 03-2695-9 and part number 03-2795-7, which were manufactured between June 11, 2010 and Oct. 17, 2010. Part number 03-2695-9 was distributed between August 2010 and November 2010 and part number 03-2795-7 was distributed between August 2009 and November 2010.

According to the FDA, "on Nov. 19, 2010, the company sent their customers an 'Urgent Recall' letter by certified mail with return receipt. 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. Customers were instructed to contact the company for instructions on how to return the recalled products."

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