Ameda, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1327-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 12, 2015

Date Posted: April 1, 2015

Recall Number: Z-1327-2015

Event ID: 70599

Reason for Recall:

Devices were not sterilized

Status: Terminated

Product Quantity: 12 collection systems

Code Information:

SKU 17115; Lot 5B01

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.

Voluntary or Mandated:

Voluntary: Firm initiated