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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: Class I Recall - Potential for Kinking of Arterial Line
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:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[01/20/2011 - Recall Notice - FDA]