Recall Z-1327-2015— Ameda, Inc.

Name: FDA recall Z-1327-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-12

Class II · Terminated

Class II FDA medical device recall by Ameda, Inc., initiated 2015-02-12, terminated 2017-07-21. It names one FDA 510(k) clearance: K011519. Product: 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: Devices were not sterilized.

Recalling firm: Ameda, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-02-12
Terminated: 2017-07-21
Firm location: Buffalo Grove, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K011519 — AMEDA HYGIENIKITHollister, Inc.·cleared 2001-08-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.