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U.S. Department of Health and Human Services

Class 2 Device Recall Playtex Nurser Deluxe Double Electric Breast Pump

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  Class 2 Device Recall Playtex Nurser Deluxe Double Electric Breast Pump see related information
Date Initiated by Firm March 18, 2014
Date Posted April 04, 2014
Recall Status1 Terminated 3 on June 10, 2016
Recall Number Z-1336-2014
Recall Event ID 67597
510(K)Number K061013  
Product Classification Pump, breast, powered - Product Code HGX
Product Playtex Nurser Deluxe Double Electric Breast Pump, Model X06578AO, powered by a 12V DC power supply, Model SY-12120, which is included with the package.
Code Information Suspect date codes for Breast Pumps: P12324-91667C to P13205-30673C. Suspect adaptor date codes: 1241 to 1324. 9/9/2014 Expanded recall: Suspect date codes for Breast Pumps: P12315-XXXX to P13205-XXXX. Suspect adaptor date codes: 1238 to 1324.
Recalling Firm/
Manufacturer		 Energizer Personal Care
6 Research Dr
Shelton CT 06484-6228
For Additional Information Contact
203-526-3120
Manufacturer Reason
for Recall		 Some of the power adapters outer casings may become loose and separate, resulting in a potential for electric shock.
FDA Determined
Cause 2		 Component change control
Action Energizer sent and Voluntary Retail Recall Notice letter dated March 18, 2014 to retail customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to stop sale and return the affected product. The letter provides instruction to customers to return the affected product. For questions or concerns, contact Energizer Personal Care at 1-888-207-1492 or visit www.playtexproducts.com. On 9/9/2014 the firm expanded the recall to one additional production lot to include: Suspect date codes for Breast Pumps: P12315-XXXX to P13205-XXXX. Suspect adaptor date codes: 1238 to 1324 Revised Press issued 9/9/2014.
Quantity in Commerce 35,803
Distribution USA Nationwide Distribution in the states of: AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, MD, MI, MN, MO, NC, NJ, NV, NY, OH, ON, OR, PA, SC, TN, TX, VA, VT, WA, WI Canada - one consignee, Energizer (recalling firm's) company store
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HGX and Original Applicant = PLAYTEX PRODUCTS, INC.
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