FDAFebruary 12, 2015device
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 ...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Devices were not sterilized
What to do
FDA enforcement status: Terminated
Brands named
ameda
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAPurely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to express and collect the mother s milk from the breasts of a nursing woman for the purpose of feeding the collected milk to a baby.2017-07-10
- FDAAmeda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63 x 3.75") within a secondary corrugated shipper (16 x 11.02 x 5.12" inner dimensions). The device is indicated for assisted expression of milk using manual suction.2015-02-12
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