FDA Recall Terminated

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.

Recall: Z-1327-2015 · Initiated February 12, 2015

Recall

Recall Number: Z-1327-2015
Event Number: 70599
Firm: Ameda, Inc.
FEI Number: 3009974348
Product Code: HGY
Status: Terminated
Root Cause: Under Investigation by firm
Initiated: February 12, 2015
Posted: March 26, 2015
Terminated: July 21, 2017
Address: 485 E Half Day Rd, Ste 320, Buffalo Grove, IL, 60089-8806

Description

Reason

Devices were not sterilized

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.

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.

Quantity

12 collection systems