In the warning letter The FDA also states that numerous...
Electrical Shock Lawsuit
Electrical Shock Not Properly Investigated
The Evenflo Co. received a warning letter from the Food & Drug Administration dated August 25 stating that company did not properly investigate reports that the “Comfort Select” breast pumps that they manufacture cause women to suffer electric shocks. Evenflo received 37 complaint form buyers of the breast pumps, but failed to investigate 18 of them. Of these complaints, 3 involved electric shocks. An official from Evenflo told The Wall Street Journal that the problem was a “documentation issue” and that the company does investigate its consumer complaints.
In the warning letter The FDA also states that numerous manufacturing violations were found during inspection earlier this year at two Ohio plants that make the pumps. According to the warning letter Evenflo could not verify or validate that they took the required corrective and preventive actions to avoid an adverse affect on the finished devices. Evenflo responded to this finding by stating that corrective action did not apply to the Comfort Select breast pumps it sold prior to December 2008.
The FDA gave Evenflo 15 working days from the date they received the warning letter to notify them of the step taken to correct the violations noted. Failure to follow the procedure would result in FDA taking regulatory actions that include but are not limited to seizure, injunction, or civil money penalties against Evenflo.