Devices

Device Recall Ameda

  • Model / Serial
    SKU 17115; Lot 5B01
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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.
  • Manufacturer
    Ameda, Inc.
  • 1 Event

Manufacturer

Ameda, Inc.
  • Manufacturer Address
    Ameda, Inc., 485 E Half Day Rd Ste 320, Buffalo Grove IL 60089-8806
  • Manufacturer Parent Company (2017)
    Ameda Inc.
  • Source
    USFDA

One device with a similar name

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Device Recall Ameda
  • Model / Serial
    SKU 17161; Lot 5A22
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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
    Ameda, Inc.