Events

Device Recall Elutia Hubless Coated Silicone Wound Drain 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Bacterin International, 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
    64326
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0936-2013
  • 사례 시작날짜
    2013-01-28
  • 사례 출판 날짜
    2013-03-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-07-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115836
  • 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
    Drainage catheter with antibiotic - Product Code OEI
  • 원인
    A portion of a silicone wound drain was found to be cracked.
  • 조치
    Consignees were informed of the recall via e-mail beginning 1/28/13 with a request for a return response. This was followed by a "Voluntary Product Recall Information" letter dated 2/13/13 that described the product issue and provided recommended actions. The firm asked for all product to be returned to them.

Device

Device Recall Elutia Hubless Coated Silicone Wound Drain
  • 모델명 / 제조번호(시리얼번호)
    005312; 011012; 012111; 012311; 012511; 013011; 019212; 023611; 023811; 024011; 024211; 025912; 033611; 042211
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    13 US consignees located in CA, CO, MT, TX, UT, and VA. This represents 4 customers and 9 other individual contacts in USA that received marketing samples. Plus 4 Bacterin representives nationwide received samples. Foreign Consingee
  • 제품 설명
    Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. Indicated for use in surgical wound drainage.
  • Manufacturer
    Bacterin International, Inc.

Manufacturer

Bacterin International, Inc.
  • 제조사 주소
    Bacterin International, Inc., 600 Cruiser Ln, Belgrade MT 59714-9719
  • 제조사 모회사 (2017)
    Xtant Medical Holdings, Inc.
  • Source
    USFDA