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U.S. Department of Health and Human Services

Class 2 Device Recall Ameda

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 Class 2 Device Recall Amedasee related information
Date Initiated by FirmFebruary 12, 2015
Date PostedMarch 26, 2015
Recall Status1 Terminated 3 on July 21, 2017
Recall NumberZ-1327-2015
Recall Event ID 70599
510(K)NumberK011519 
Product Classification Pump, breast, non-powered - Product Code HGY
ProductAmeda 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 2
Under Investigation by firm
ActionAmeda 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 Commerce12 collection systems
DistributionNationwide 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 CycleTPLC 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) Database510(K)s with Product Code = HGY
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