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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.
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