FDA Device

Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2695-9

Hazard

Hemodialysis Blood tubing Sets may develop kinking of the arterial line.

What You Should Do

Remedy

Fresenius Medical issued recall notification dated 11/19/10, "URGENT RECALL FMCNA Combiset BVM Hemodialysis Blood Tubing Sets (Part Numbers 03-2695-9 and 03-27957)", by certified mail with return receipt. Customers have been instructed to check their stock immediately to determine if they have any affected lots on hand. If customers have the affected lots, they have been instructed to discontinue use immediately and place the product in a secure segregated area for return to Fresenius Medical Care North America. Customers have been instructed to contact Fresenius Medical Care Customer Service Team Representative for instructions on how to return the recalled product.

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Products

Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2695-9
Brand
Fresenius Medical Care Holdings, Inc.
UPC
Lots 10HR01065, 10HR01083, 10HR01197, 10HR01259, 10JR01019, 10JR01031, 10JR01040, 10JR01058, 10JR01067, 10JR01077, 10JR01239, 10LR01041, 10LR01041, 10LR01053, 10LR01061, 10LR01070, 10LR01102, 10LR01111, 10LR01123, 10LR01269, 10LR01282, 10LR01283, 10LR01284, 10LR01285, 10NR01020, 10NR01031, 10NR01041, 10NR01050, 10NR01146, 10NR01157, 10NR01169, 10NR01180

Units Affected

190,080 units (7920 cases x 24 units)

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