FDA Medical Device Recalls (openFDA)
Ameda, Inc.: 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 number
- Z-1327-2015
- Recalling firm
- Ameda, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2015-02-12
- Posted
- 2015-03-26
- Terminated
- 2017-07-21
- Reason
- Devices were not sterilized
- Root 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
- 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.
- Lot, serial or model codes
- SKU 17115; Lot 5B01
- 510(k) numbers
- ["K011519"]
- PMA numbers
- not on file
- Product code
- HGY
- Firm FEI
- 3009974348
- Firm city
- Buffalo Grove
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28