Events

SHARPOINT IQ Geometry Slit Knives 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Surgical Specialties Puerto Rico Inc. dba Angiotech PR 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
    62945
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0202-2013
  • 사례 시작날짜
    2012-08-15
  • 사례 출판 날짜
    2012-11-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-01-13
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112325
  • 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
    Blade, scalpel - Product Code GES
  • 원인
    Potential for bent tips.
  • 조치
    Angiotech sent an Urgent Product Recall Notification letter dated August 15, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the current inventory, segregate the affected lot numbers, and to return the identified product. Customers were asked to complete the attached Customer Acknowledgement Form and fax to the Quality Assurance department at 787-658-1073. If product was further distributed customers should notify their customers to whom they sold the affected product. Customers with questions should call 787-658-1800 option 2 ext. 1775 or 787-658-1800 option 2 ext 1807. For questions regarding this recall call 787-658-1800.

Device

SHARPOINT IQ Geometry Slit Knives
  • 모델명 / 제조번호(시리얼번호)
    M342500, M342510, M415840, M439130, M446040, M495130, M495160, M510810, M553460, M553470, M553480, M585640, M585740, M652760, M652770, M652780, MADP160, MADP170
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including DE,IL, NC, CA, CO, GA, KY, PA, MD, MN, NY, and MA and internationally to Austria, UAE, China, Argentina, Italy, Taiwan, Czech Republic, Australia, UK, India, Germany, Spain, France, South Africa, Malaysia, Japan, Lebanon, Korea, Greece, Saudi Arabia, Switzerland, Pakistan, Tunisia, Serbia, Morocco, Netherlands, Portugal, Truk, Belgium, and New Zealand
  • 제품 설명
    "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2840***" || Ophthalmic surgery
  • Manufacturer
    Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.

Manufacturer

Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
  • 제조사 주소
    Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc., Rd 459 Km 0.6, Montana Industrial Park, Aguadilla PR 00605
  • 제조사 모회사 (2017)
    Angiotech Pharmaceuticals, Inc.
  • Source
    USFDA