Z-0616-2018Class III

Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to express and collect the mother s...

Name: Z-0616-2018 Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to express and collect the mother s...
Creator: Ameda, Inc.
Published: 2017-07-10
License: https://open.fda.gov/license/

Ameda, Inc. / initiated 2017-07-10 / Open, Classified / root cause: manufacturing process

FDA source

AMEDA, INC. began a recall of 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... on 2017-07-10. FDA classified it as Class III and gives the reason as "Two specific lots was incorrectly manufactured containing a UK power adapter". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0616-2018
Classification: Class III
Status: Open, Classified
Initiated: 2017-07-10
Posted: 2018-02-15
Recalling firm: Ameda, Inc.
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.
Product code: HGX Pump, Breast, Powered
Reason for recall: Two specific lots was incorrectly manufactured containing a UK power adapter.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Customers were notified initially by phone call on 07/10/2017 and "Device Recall" letters were mailed, via FedEx overnight delivery on 07/10/2017. Instructions included to place any affected product in quarantine, complete and return Correction Response Form, return any product in inventory, notify customers if further distributed, and that replacement product will be provided upon return of their customer's completed Correction Response Form. Any questions can be directed to Ameda at 877-992-6332, press #1. The recall was expanded on 08/18/2017 and customers were notified by letter, via FedEx, on 08/18/2017 through 08/22/2017. Instructions are the same as the initial notification above.
Quantity in commerce: 3,327 units total
Distribution: Distributed to CA, DC, DE, FL, GA, IL, MD, NC, NJ, OH, TX, UT, VA, and WA.
Product codes and lots: Lot 7E058 and Lot 7E308

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0616-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0616-2018	Class III	Ongoing	Voluntary: Firm initiated	2018-02-21	2018-02-15

Product code HGX

K973501Class IIExpresse and Premier Powered Breast PumpsAmeda Medizintechnik AG / cleared 1997-12-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)