Events

Rappel de Device Recall Playtex Nurser Deluxe Double Electric Breast Pump

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Energizer Personal Care.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    67597
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1336-2014
  • Date de mise en oeuvre de l'événement
    2014-03-18
  • Date de publication de l'événement
    2014-04-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-06-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125810
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Pump, breast, powered - Product Code HGX
  • Cause
    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
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Obstetrical and Gynecological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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
  • Description du dispositif
    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
  • Adresse du fabricant
    Energizer Personal Care, 6 Research Dr, Shelton CT 06484-6228
  • Source
    USFDA