Events

3M Universal Electrosurgical Pad 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 3M Company - Health Care Business 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
    75644
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0701-2017
  • 사례 시작날짜
    2016-10-26
  • 사례 출판 날짜
    2016-12-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-08-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150979
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • 원인
    3m is recalling universal electrosurgical pads because a report of an unintended material (process liner) in the product. this may prevent or impede the safe return of electrosurgical current following electrosurgical unit (esu) activation. this defect has the potential to increase the risk of a patient burn directly under the pad or at an alternate site of the body.
  • 조치
    3M sent an Urgent Medical Device Recall letter dated October 26, 2016 to affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to complete and return the attached Customer Product Return and Recall Form. Customers with questions can contact 3M Health Care Customer Helpline at 1-800-228-3957, 8:30 am - 7:00 pm EST.

Device

3M Universal Electrosurgical Pad
  • 모델명 / 제조번호(시리얼번호)
    Product REF 9130 Lot Numbers: 2019-02DT (Expiration 02-2019) and 2019-03DU (Expiration 03-2019) Product REF 9735-LP Lot Numbers: 2019-02DB and 2019-02CY. (Both with Expiration 02-2019)
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the states of AR, AZ, CA, FL, GA, ID, IL, KY, NC, NY, TN, TX, VA and the countries of Canada, Chile, Costa Rica, Germany, Japan, Mexico and South Africa.
  • 제품 설명
    3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and || 3M Universal Electrosurgical Pad with Cord, REF 9135-LP (40 pads / case) || Product Usage: || 3M Universal Electrosurgical Pads are designed to work with most electrosurgical unite (ESU) for virtually every surgical application where electrosurgery is utilized to provide a safe return path for electrosurgical current. Solid Universal Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System (CQMS). Split Style Universal Electrosurgical Pad is for use with ESUs that have a CQMS (i.e. REM, ARM, NESSY, etc.). 3M Universal Electrosurgical Pads are designed to be used on any patient where full skin contact and a suitable placement site can be obtained. There are no patient weight restrictions for use of this product. Use of this product for unintended application could lead to an unsafe condition.
  • Manufacturer
    3M Company - Health Care Business

Manufacturer

3M Company - Health Care Business
  • 제조사 주소
    3M Company - Health Care Business, 3m Center 2510 Conway Ave , B# 275-5-W-6, Saint Paul MN 55144-0001
  • 제조사 모회사 (2017)
    3m Company
  • Source
    USFDA