FDAFDA · Food and drugs·Recall number Z-1327-2015
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.
Published April 1, 2015 · Recall initiated: February 12, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Devices were not sterilized
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ameda, Inc.
- Distributor
- 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
- SKU 17115; Lot 5B01
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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