Home / Recalls / Ameda, Inc. / Z-1326-2015

Z-1326-2015 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
1763

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.

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 17161; Lot 5A22

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-1327-2015 Class II — Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary p (February 12, 2015)