Device 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.
Z-1327-2015
Product summary
- Firm
- Ameda, Inc.
- Event
- Event 70599
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 collection systems
- Official record key
device-enforcement:Z-1327-2015
Official wording
Reason: Devices were not sterilized
Code information: SKU 17115; Lot 5B01
Distribution pattern: 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.
Derived failure modes
-
Unknown
Devices were not sterilized