Class 2 Device Recall Ameda

• Date Initiated by Firm: February 12, 2015
• Date Posted: March 26, 2015
• Recall Status: Terminated on July 21, 2017
• Recall Number: Z-1327-2015
• Recall Event ID: 70599
• 510(K)Number: K011519
• Product Classification: Pump, breast, non-powered - Product Code HGY
• Product: Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouches with Tyvek header (10.75 x 16.375 x 3") within a secondary corrugated shipper (20.75 x 15.50 x 8.5" inner dimensions).; The device is intended to be connected to a powered breast pump or adapted for use with a manual breast pump to express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby.
• Code Information: SKU 17115; Lot 5B01
• Recalling Firm/ Manufacturer: Ameda, Inc.; 485 E Half Day Rd Ste 320; Buffalo Grove IL 60089-8806
• For Additional Information Contact: 847-964-2645
• Manufacturer Reason for Recall: Devices were not sterilized
• FDA Determined Cause: Under Investigation by firm
• Action: Ameda sent an URGENT: MEDICAL DEVICE RECALL letter dated February 12, 2015 to all affected customers. The letter included instructions for distributors to: 1) quarantine the recalled products; 2) complete and return the enclosed Recall Response Forms within 3 days of receiving the letter; 3) upon receipt of the completed Recall Response Form, an Ameda representative would contact the distributor to make arrangements for the return of the recalled products; 4) Ameda will use the information provided in the returned Recall Response Form to contact the distributor's customers of record to arrange for the return of recalled product that was already shipped to the customers of record; and, 5) replacement product will be shipped to both distributors and their customers of record upon receipt of the completed Recall Response Form. Questions about this recall will be answered by Ameda personnel who can be reached at 847-964-2645.
• Quantity in Commerce: 12 collection systems
• Distribution: Nationwide Distribution including CA, FL, GA, IA, IL, IN, LA, MA, MD, MO, MS, NC, NJ, NY, OK, PA, RI, SC, TN, TX, UT, VA, and WA.
• 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 = HGY and Original Applicant = HOLLISTER, INC.