IMPORTANT: FIELD ACTION
April 4, 2011
Re: Safety Notification – Power Adaptor (Transformer)
This letter is to notify you that Medela, Inc. is initiating a safety notification on the power adaptor (also referred to as the transformer) used with the Pump In Style® Advanced (PNSA) family of breast pumps. We want to inform you that when not handled properly, a small percentage of these power adaptors can develop damage in the form of twists, kinks, bends, bulges or exposed wires in the cord. Medela has had reports of power adaptors being used after the cord has been damaged.
The following is stipulated in Medela’s Instruction For Use manual sent with every PNSA breastpump:
“Warning: To reduce the risk of burns, electrocution, fire or injury to persons:
1. A product should never be left unattended when plugged into an electric outlet.
2. Close supervision is necessary when this product is used, on, or near children or invalids.
3. Use the product only for its intended use as described in this manual. Do not use attachments not recommended by the manufacturer.
4. Never operate this product if it has a damaged cord or plug, if it is not working properly, if it has been dropped or damaged, or dropped into water.
5. Keep the cord away from heated surfaces.”
If the power adaptor is not damaged, it is safe for use. There have been no reported injuries related to the power adaptor. If you have a damaged power adaptor (or power adaptor cord) please discontinue use and visit our website, at www.MedelaPowerAdaptorHelp.com to request a replacement adaptor. Customer Service is also available to assist you at 855-367-0104 or email at email@example.com if you have any questions.
THIS NOTICE DOES NOT PERTAIN TO THE BREASTPUMP ITSELF. It only applies to the power adaptor article #9207010 pictured below.
Bryan T Sowatzke
Manager, Regulatory Affairs