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.
- Company
- Ameda, Inc.
- Recall Initiated
- July 10, 2017
- Recall Number
- Z-0616-2018
- Quantity
- 3,327 units total
- Firm Location
- Buffalo Grove, IL
Reason for Recall
Two specific lots was incorrectly manufactured containing a UK power adapter.
Distribution
Distributed to CA, DC, DE, FL, GA, IL, MD, NC, NJ, OH, TX, UT, VA, and WA.
Lot / Code Info
Lot 7E058 and Lot 7E308
Root Cause
Employee error
Action Taken
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.