Events

Recall of Device Recall Playtex Nurser Deluxe Double Electric Breast Pump

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Energizer Personal Care.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67597
  • Event Risk Class
    Class 2
  • Event Number
    Z-1336-2014
  • Event Initiated Date
    2014-03-18
  • Event Date Posted
    2014-04-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125810
  • Notes / Alerts
    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.
  • Extra notes in the data
    Pump, breast, powered - Product Code HGX
  • Reason
    Some of the power adapters outer casings may become loose and separate, resulting in a potential for electric shock.
  • 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.

Device

Device Recall Playtex Nurser Deluxe Double Electric Breast Pump
  • Model / Serial
    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.
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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
  • Product Description
    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.
  • Manufacturer
    Energizer Personal Care

Manufacturer

Energizer Personal Care
  • Manufacturer Address
    Energizer Personal Care, 6 Research Dr, Shelton CT 06484-6228
  • Source
    USFDA