Fresenius Medical Care North America, CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Pr
Posted Jan 21 2011 10:50am
AUDIENCE: Nephrology/dialysis, Risk Manager
ISSUE: 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.
This recall affects ONLY Part Number 03-2695-9 and Part Number 03-2795-7.
These products were manufactured between June 11, 2010 and October 17, 2010. Part Number 03-2695-9 was distributed between August 2010 and November 2010. Part Number 03-2795-7 was distributed between August 2009 and November 2010.
BACKGROUND: The CombiSet Hemodialysis Blood Tubing Set is blood tubing used during hemodialysis. It is intended for single use only. The CombiSet Hemodialysis Blood Tubing Set may be used with conventional and high flux negative pressure hemodialyzer equipment.
RECOMMENDATION: Customers should immediately discontinue using the affected lots and place the products in a secure and separate area for return to the company.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: