Events

THERA PEARL 3in1 BREAST THERAPY 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Lansinoh Laboratories Inc 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
    63390
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0784-2013
  • 사례 시작날짜
    2012-08-14
  • 사례 출판 날짜
    2013-02-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-03-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115101
  • 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
    Pack, hot or cold, reuseable - Product Code IME
  • 원인
    The spanish translation on the instructions for use (ifu) insert and product package for hot and cold packs has incorrect heating instructions which would cause product to over heat.
  • 조치
    Lansinoh Laboratories, Inc. sent an Urgent Product Recall letter dated August 14, 2012, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to stop distributing and quarantine the affected product. Customers were informed that a credit would be issued for the affected product and they were asked to mail the postage paid Business Reply Card even if they do not have the affected product. If necessary call 1-877-366-1182 to arrange pickup. For questions customers were instructed to call the Customer Service Center at 1-800-292-4794. For questions regarding this recall call 703-299-6477.

Device

THERA PEARL 3in1 BREAST THERAPY
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers 100/12/01, 116/12/01, 108/12/01, 109/12/01, 149/12/01
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution, including the states of TX, CA, NJ, NY, SD, RI, WV, IL PA, NC and MN.
  • 제품 설명
    THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. || The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage let-down while using a breast pump.
  • Manufacturer
    Lansinoh Laboratories Inc

Manufacturer

Lansinoh Laboratories Inc
  • 제조사 주소
    Lansinoh Laboratories Inc, 333 N Fairfax St Ste 400, Alexandria VA 22314-2632
  • 제조사 모회사 (2017)
    Pigeon Corp.
  • Source
    USFDA