FDA-Device2015-04-01Class II
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.
Ameda, Inc.
Hazard
Devices were not sterilized
Sold states
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.
Affected count
1763
Manufactured in
485 E Half Day Rd Ste 320, Buffalo Grove, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1326-2015Don't want to check this manually?
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