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www.fdanews.com/articles/114563-fda-warns-company-for-releasing-nonconforming-devices

FDA Warns Company for Releasing Nonconforming Devices

February 13, 2009
I-Flow Corp. allegedly distributed devices that did not meet its output validation criteria and then downplayed the nonconformances in its corrective action procedures, according to an FDA warning letter. The California company, which manufactures elastomeric infusion pumps, did not test the devices during or after design output procedures to ensure they met design specifications for correct flow rates, which is “essential to verifying that the device is functioning,” the letter says.
Devices & Diagnostics Letter