Device Recall Cardinal Health Gomco Style Circumcision Clamp Trays 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cardinal Health 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
    73497
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1320-2016
  • 사례 시작날짜
    2016-02-29
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Circumcision tray - Product Code OHG
  • 원인
    Two lots of gomco style circumcision clamp trays, ssi-0034 and 10-1100 contained a 1.3cm circumcision clamp. they both were labelled as containing a 1.1cm clamp.
  • 조치
    Cardinal Health sent an URGENT: PRODUCT RECALL letter dated February 29, 2016, to affected consignees explaining the reason for the product recall and actions that should be taken by the end user. These included the following actions: 1. STOP using affected product. 2. RETURN the enclosed acknowledgment form via fax to 847-689-9101 or 614-652- 9648, whether or not you have affected product, as Cardinal Health is required to confirm receipt of this notification from you, and to prevent further notices. 3. NOTIFY any customers to whom you may have distributed product affected by this recall. 4. CONTACT the appropriate Customer Service group to arrange for return of any affected product you may have: " Hospital800.964.5227 " Distributor800.635.6021 The firm asks that consignees who have question or requests of special assistance relating to the recall should contact Cardinal Health Customer Advocacy at 800.292.9332. For questions regarding this recall call 847-473-1500.

Device

  • 모델명 / 제조번호(시리얼번호)
    SSI-0034 with LOT# 462799 & 476803  10-1100 with LOT# 462788 & 485406
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including AR, KS, WV, , NC, TX, AL, MS and VA.
  • 제품 설명
    Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Cardinal Health, 1430 Waukegan Rd, Mc Gaw Park IL 60085-6726
  • 제조사 모회사 (2017)
  • Source
    USFDA