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Ameda, Inc. recalls Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63 x 3.75") w
Recalled April 1, 2015 · FDA recall Z-1326-2015 · Ameda
Hazard
Devices were not sterilized · FDA Class II
Units
1763
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 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.
Manufacturer(s)
Ameda, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →