Recall Z-1326-2015— Ameda, Inc.

Name: FDA recall Z-1326-2015
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: K912355. Product: 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: 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

K912355 — MOTHERS TOUCH ONE HAND BREAST PUMPHollister, Inc.·cleared 1993-12-10

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 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

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