Medela Gets a Stern Letter from the FDA

Major breastpump manufacturer, Medela, got a letter February 25th from the FDA about their non-compliance with manufacturing laws for medical devices.

Medela issued a recall for Pump in Style breastpumps on January 11, 2011.  The company's website says, "pumps affected by this recall were manufactured between February 10, 2010 and March 3, 2010 and shipped between February 10, 2010 and April 30, 2010.  These pumps would have been purchased by mothers between approximately March 1 and June 30, 2010."
Medela Pump in Style Advanced Breast Pump with On the Go Tote

The FDA says that Medela was receiving complaints about the pumps smoking, catching fire, and losing suction as early as July 2010.  Medela allegedly did not address the problem adequately.  The FDA says that Medela didn't keep proper records of customer complaints, did not adequately investigate the electrical defects, and did not alert the FDA to the problems within 30 days.

The FDA letter says "the methods used in, or the facilities or controls used for, [the devices'] manufacture, processing, packing, or holding are not in conformity with the current good manufacturing practice (CGMP) requirements."

It also says that, "the specific violations noted in this letter...may be symptomatic of serious problems in your firm’s manufacturing and quality management systems."

To return a defective pump to Medela email or call 1-800-435-8316 to talk to Medela customer service.