Events

Device Recall Playtex Nurser Deluxe Double Electric Breast Pump 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Energizer Personal Care 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    67597
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1336-2014
  • 사례 시작날짜
    2014-03-18
  • 사례 출판 날짜
    2014-04-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-06-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125810
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Pump, breast, powered - Product Code HGX
  • 원인
    Some of the power adapters outer casings may become loose and separate, resulting in a potential for electric shock.
  • 조치
    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
  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
    Obstetrical and Gynecological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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
  • 제품 설명
    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
  • 제조사 주소
    Energizer Personal Care, 6 Research Dr, Shelton CT 06484-6228
  • Source
    USFDA