FDAnews Device Daily Bulletin

Fresenius Warning Letter Cites Uncleared, Recalled Design Changes

May 25, 2011
Fresenius Medical Care Holdings has received an FDA warning letter for making uncleared design changes to a dialysis device that later led to a product recall. The German company sent the FDA information on a recall of its modified CombiSet hemodialysis blood tubing sets that showed it had implemented design changes prior to the recall, according to the April 6 warning letter posted online last month. Fresenius later recalled the modified set due to a device failure related to the design change. However, it told the FDA that its design validations had not raised any new issues or unexpected results regarding performance, safety or effectiveness.
The GMP Letter