Events

Lipo Pack, Liposuction Expended Pack, and Liposuction Tray contains Devon Light Glove 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stradis Healthcare, LLC. 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
    71130
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1999-2015
  • 사례 시작날짜
    2015-04-20
  • 사례 출판 날짜
    2015-07-07
  • 사례 상황
    Completed
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137280
  • 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
    General surgery tray (kit) - Product Code LRO
  • 원인
    Convenience kits being recalled due to the recall by the manufacturer (medtronic) of a component (devon light glove) contained in the kits.
  • 조치
    Medtronic sent an Urgent Medical Device Recall letter dated April 16, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to quarantine and discontinue use of the affected device. Complete the Recalled Product Return Form and fax to 800-895-6140 or email to feedback.customerservice@Covidien.com. Customers with questions regarding return of the product should call 1-727-642--4124.

Device

Lipo Pack, Liposuction Expended Pack, and Liposuction Tray contains Devon Light Glove
  • 모델명 / 제조번호(시리얼번호)
    Pack 681-025, 681-268, 681-254, 681-013, 681-506, 888-2587
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution US nationwide to AL, AK, CA, DE, FL, GA, HI, ID, IL, IN, KS, KY, ME, MD, MA, MI, MS, MO, NM, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA; Canada and Dubai
  • 제품 설명
    Lipo Pack, Liposuction Expended Pack, and Liposuction Tray - contains Devon Light Glove || Used during surgery
  • Manufacturer
    Stradis Healthcare, LLC.

Manufacturer

Stradis Healthcare, LLC.
  • 제조사 주소
    Stradis Healthcare, LLC., 805 Marathon Pkwy Ste 100, Lawrenceville GA 30046-2885
  • 제조사 모회사 (2017)
    Stradis Healthcare
  • Source
    USFDA