Fresenius Medical Care AG & Co. KGaA’s (NYSE:FMS) North American subsidiary announced a voluntary recall of a hemodialysis blood tubing set and related components.
Due to reports of arterial line kinks, Fresenius Medical Care North America recalled lots of its CombiSet True Flow Series hemodialysis blood tubing set with priming set and transducer protectors — part numbers 03-2695-9 and 03-2795-7 — for use with the company’s blood volume monitor, the company said in a prepared statement.
No deaths or serious injuries due to malfunctions in the recalled products have been reported, but the Food & Drug Administration classified the action as a Class I recall, the agency’s most serious.
The Waltham, Mass.-based company distributed the lots for the affected components between Aug. and Nov. 2010, according to the company.
For part number 03-2695-9, the recall affects the following lot umbers: 10HR01065, 10HR01083, 10HR01197, 10HR01259, 10JR01019, 10JR01031, 10JR01040, 10JR01058, 10JR01067, 10JR01077, 10JR01239, 10LR01041, 10LR01053, 10LR01061, 10LR01070, 10LR01102,10LR01111, 10LR01123, 10LR01269, 10LR01282, 10LR01283, 10LR01284, 10LR01285, 10NR01020, 10NR01031, 10NR01041, 10NR01050, 10NR01146, 10NR01157, 10NR01169, 10NR01180
For part number: 03-2795-7, the recall affects the following lot numbers 09JR01174, 09JR01229, 09NR01139, 10KR01801
Healthcare providers with questions about the recalled products should call Fresenius customer service 1-800-323-5188 in or United States or 1-888-709-4411 in Canada.
The news of the recall was buffered by the announcement of an agreement with the public health authorities of the Murcia region of Spain for a comprehensive dialysis care and performance-oriented payment model. The contract is the first of its type for the country, according to the company.
The deal stipulates that Fresenius will provide dialysis therapy to about 200 patients beginning in mid-2011, and reimbursement for the treatment will be converted to an all-inclusive bundled rate that is tied to the company’s quality performance. It currently provides dialysis treatment in Murcia on a fee-for-service basis.