CombiSet True Flow Series Hemodialysis Blood Tubing Sets Subject to Class I Recall

The <"">CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors for Use with the Blood Volume Monitor has been recalled in a Class I Recall, the U.S. Food and Drug Administration (FDA) just announced. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

This recall affects ONLY Part Number 03-2695-9 and ONLY Part Number 03-2795-7. Specific lot numbers can be found on the Fresenius Medical Care press release at: The recall was issued by Fresenius Medical Care Holdings, Inc.
920 Winter Street 
Waltham, Massachusetts 02451-1521.

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.

The CombiSet Hemodialysis Blood Tubing Set is blood tubing used during hemodialysis and is intended for single use only. The CombiSet Hemodialysis Blood Tubing Set may be used with conventional and high flux negative pressure hemodialyzer equipment.

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.

On November 19, 2010, the company sent its 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.

Clinic Managers, Unit Administrators, and/or distributors with questions may contact the Fresenius Medical Care Customer Service Team, toll-free, at 1-800-323-5188.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

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