Reported Apr 1, 2015 · Terminated
Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouches with Tyvek…
Ameda, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ameda, Inc. · 485 E Half Day Rd Ste 320 · Buffalo Grove, IL · 60089-8806
Is this the product you have?
- 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.
- Lot codes and dates
SKU 17115Lot 5B01
- Amount recalled
- 12 collection systems
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Devices were not sterilized
This product could cause temporary or reversible health problems — stop using it.
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