Home / Recalls / Ameda, Inc. / Z-1327-2015

Z-1327-2015 Class II Terminated

Recalled by Ameda, Inc. — Buffalo Grove, IL

Recall Details

Product Type
Devices
Report Date
April 1, 2015
Initiation Date
February 12, 2015
Termination Date
July 21, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12 collection systems

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.

Reason for Recall

Devices were not sterilized

Distribution Pattern

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.

Code Information

SKU 17115; Lot 5B01

Other recalls by Ameda, Inc.

  • Z-0616-2018 Class III — Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to exp (July 10, 2017)
  • Z-1326-2015 Class II — Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches w (February 12, 2015)