Class 2 Device Recall Instructions for Use for Symphony Double Pumping Kit

• Date Initiated by Firm: March 15, 2010
• Date Posted: April 27, 2010
• Recall Status: Terminated on December 10, 2010
• Recall Number: Z-1442-2010
• Recall Event ID: 54995
• 510(K)Number: K020518
• Product Classification: pump, breast, powered - Product Code HGX
• Product: Instruction for Use for Symphony Double Pumping Kit; Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; the instructions were packaged with the following non-sterile single user accessory kits for use with Symphony breast pumps: a) Model 67023, Harmony to Symphony Conversion Kit; b) Model 67091, Lactina to Symphony Conversion Retail Kit; c) Model 67099, Symphony Retail Kit; d) Model 67099-06, Symphony Retail Kit - case of 6 kits; e) Model 67099NA, Symphony Retail Kit - case of 6 kits for national accounts
• Code Information: item #1908095, revision B 0909, contained in kits shipped between 10/23/09 and 02/02/2010
• FEI Number: 1419937
• Recalling Firm/ Manufacturer: Medela Inc; 1101 Corporate Dr; Mchenry IL 60050-7006
• For Additional Information Contact: Mr. Samuel B. Levey; 815-363-1166
• Manufacturer Reason for Recall: The non-sterile devices were erroneously packaged with instructions stating the devices are sterile and do not require cleaning before first use.
• FDA Determined Cause: Labeling Change Control
• Action: An "IMPORTANT:DEVICE RECALL" letter dated March 12, 2010 to the the customers on March 15, 2010, via certified mail, return receipt requested. The letters were tailored to each customer listing the affected shipments sent to them, and informing them of the labeling insert problem. The customers were requested to cease distribution of the affected kits and return them to the firm (Medela) for replacement, and if applicable, to notify their retail customers. The customers were instructed to call Medela Customer Service at 877-320-2301 for assistance in processing returns or for further clarification on the recall.
• Quantity in Commerce: 13,834 kits
• Distribution: Nationwide distribution
• 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