U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Pump, breast, powered - Product Code HGX
원인
Two specific lots was incorrectly manufactured containing a uk power adapter.
조치
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.
Distributed to CA, DC, DE, FL, GA, IL, MD, NC, NJ, OH, TX, UT, VA, and WA.
제품 설명
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.