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Ameda, Inc. recalls Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouches with Tyvek header
Recalled April 1, 2015 · FDA recall Z-1327-2015 · Ameda
Hazard
Devices were not sterilized · FDA Class II
Units
12 collection systems
Sold at
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.
Description
Devices were not sterilized
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.
Manufacturer(s)
Ameda, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →