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U.S. Department of Health and Human Services

Class 3 Device Recall Purely Yours Breast Pumps

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 Class 3 Device Recall Purely Yours Breast Pumpssee related information
Date Initiated by FirmJuly 10, 2017
Create DateFebruary 15, 2018
Recall Status1 Open3, Classified
Recall NumberZ-0616-2018
Recall Event ID 78237
510(K)NumberK973501 
Product Classification Pump, breast, powered - Product Code HGX
ProductPurely 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.
Code Information Lot 7E058 and Lot 7E308
Recalling Firm/
Manufacturer		 AMEDA, INC.
485 E Half Day Rd Ste 320
Buffalo Grove IL 60089-8806
For Additional Information Contact
877-992-6332
Manufacturer Reason
for Recall		Two specific lots was incorrectly manufactured containing a UK power adapter.
FDA Determined
Cause 2		Employee error
ActionCustomers 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 Commerce3,327 units total
DistributionDistributed to CA, DC, DE, FL, GA, IL, MD, NC, NJ, OH, TX, UT, VA, and WA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = HGX
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