Recall Z-0616-2018 ยท HGX Pump, Breast, Powered
AMEDA, INC.
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.
| Date | Jul 10, 2017 |
| Status | Open, Classified |
| Reason | Two specific lots was incorrectly manufactured containing a UK power adapter. |
| 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 |
| Quantity | 3,327 units total |
| Distribution | Distributed to CA, DC, DE, FL, GA, IL, MD, NC, NJ, OH, TX, UT, VA, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973501 | EXPRESSE AND PREMIER POWERED BREAST PUMPS Ameda Medizintechnik AG, Dec 11, 1997 |