Recall Z-0616-2018— AMEDA, INC.

Name: FDA recall Z-0616-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-10

Class III · Ongoing

Class III FDA medical device recall by AMEDA, INC., initiated 2017-07-10. It names one FDA 510(k) clearance: K973501. Product: Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to express and collect the mother s milk from the breasts of a nursing woman for the purpose of feeding the collected milk to a baby.. Reason: Two specific lots was incorrectly manufactured containing a UK power adapter..

Recalling firm: AMEDA, INC.
Classification: Class III
Status: Ongoing
Initiated: 2017-07-10
Firm location: Buffalo Grove, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K973501 — EXPRESSE AND PREMIER POWERED BREAST PUMPSAmeda Medizintechnik AG·cleared 1997-12-11

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

Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to express and collect the mother s milk from the breasts of a nursing woman for the purpose of feeding the collected milk to a baby.

Reason for recall

Two specific lots was incorrectly manufactured containing a UK power adapter.

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