Events

Device Recall GYRUS ACMI, Sterile EO 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Gyrus Medical, 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
    69226
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0100-2015
  • 사례 시작날짜
    2014-08-27
  • 사례 출판 날짜
    2014-10-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-09-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129976
  • 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
    Due to an anomaly in the packaging process, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product.
  • 조치
    Olympus sent a Medical Device Recall letter dated August 26, 2014, via FEDEX to all affected consignees. The letter described the issue and the product involved in the recall. It also described the action that the consignee needs to take. Consignees were instructed to cease further use of the device, quarantine it and return it to the manufacturer.Consigness were instructed to complete and return by fax (484-896-7128) the questionnaire enclosed. If the product was further distributed consignees should notify their customers of the product recall. For additional information they can call 484-896-5688. For questions regarding this recall call 484-896-5688.

Device

Device Recall GYRUS ACMI, Sterile EO
  • 모델명 / 제조번호(시리얼번호)
    All product manufactured before July 28, 2014.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including US: AL, AZ, CA, FL, GA, HI, IL, IN, IA, KY, MA,MI,MS, NJ, NY, NC, OH, PA, SC, TN, UT, and WA. Internationally to ITALY, SPAIN, UNITED KINGDOM, and CHINA.
  • 제품 설명
    GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm || REF 3345PK - PKS MOLly Forceps 5mm/45cm || REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm || REF 3640PK- PKS Macro Jaw Forceps 5mm/45cm || REF 3844- Everest BiCOAG LP Scissors 5mm/45cm || REF 910010PK- PKS MOLly Forceps 5mm/45cm || Single-use, sterile devices intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.
  • Manufacturer
    Gyrus Medical, Inc

Manufacturer

Gyrus Medical, Inc
  • 제조사 주소
    Gyrus Medical, Inc, 6655 Wedgwood Rd N Ste 160, Osseo MN 55311-3613
  • 제조사 모회사 (2017)
    Olympus Corporation
  • Source
    USFDA