Class 3 Device Recall Pump in Style Advanced Breast Pump

• Date Initiated by Firm: January 10, 2011
• Date Posted: February 11, 2011
• Recall Status: Terminated on May 21, 2012
• Recall Number: Z-1224-2011
• Recall Event ID: 57597
• 510(K)Number: K031614
• Product Classification: Pump, breast, powered - Product Code HGX
• Product: Pump in Style Advanced (PNSA)Breast Pump; a daily use, double pump, electric powered breast pump; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; the affected breast pumps were sold in the following configurations: a) article 57027 - Kit PNSA Shoulder Bag; b) article 57027T - Kit PNSA Shoulder Bag Tagged; c) article 57036T - Kit PNSA The Metro Bag Tagged; d) article 57043 - PNSA without kit; e) article 57062 - Kit PNSA Backpack; f) article 57062-03 - Kit PNSA Backpack CA/3; g) article 57062T - Kit PNSA Backpack Tagged; h) 57102 - Motor Replacement PNSA Backpack 57062; i) 57103 - Motor Replacement PNSA Shoulder Bag 57027 Intended use: A powered breast pump for the removal, collection and storage of mother's breast milk.
• Code Information: manufacture dates 02/10/10 through 03/03/10
• FEI Number: 1419937
• Recalling Firm/ Manufacturer: Medela Inc; 1101 Corporate Dr; Mchenry IL 60050-7006
• For Additional Information Contact: Mr. Donald J. Alexander; 815-578-2406
• Manufacturer Reason for Recall: The performance of the pumps may be compromised due to the potentiometer used on the circuit board. Affected pumps may not turn on, may turn off on its own, may reduce or lose suction during the pumping process, or may make a clicking noise.
• FDA Determined Cause: Vendor change control
• Action: This firm, Medela, sent an "Important Device Recall" letter dated January 11, 2011 to all of direct accounts via UPS or US Mail. The accounts were informed that a component on the control board, after a period of usage, may cause the motor to slow down or stop, resulting one or more of the following symptoms: the pump will not turn on; the pump turns off on its own; the pump reduces or loses suction during the pumping process or the pump is making a clicking noise. If the users have a pump that exhibits any of these symptoms, they were requested to visit Medela's website at www.medelareturns.com to expedite shipment of a replacement unit. Questions about the recall process were directed to Medela Customer Service at 1-800-435-8316 or e-mail at medelareturns@medela.com. Distributor/retailers were requested to post the recall notice within their establishment visible to their customer base, and to notify their customers of the recall. Information on the recall was posted on Medela's website www.medelareturns.com on January 11, 2011.
• Quantity in Commerce: 11,154 units
• Distribution: Nationwide, including Puerto Rico
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.

• 510(K) Database: 510(K)s with Product Code = HGX