Events

Device Recall Elutia Surgical 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
    68305
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1680-2014
  • 사례 시작날짜
    2014-05-15
  • 사례 출판 날짜
    2014-06-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-06-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127311
  • 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
    The recalling firm reported there was inadvertent omission of quarterly (q4 - 2013 and q1 - 2014) dose audits/verifications on the affected products. all of the affected products were appropriately sterilized.
  • 조치
    Bacterin sent e-mail and FedEx letter with return receipt request to it's single consignee on May 15, 2014. Consignee is asked to separate the recalled product in a secure location for return to Bacterin International, Inc. Consignee is asked to complete tracking/verification form included in the letter/e-mail and call 1-888-886-9354 from 8:00AM to 5:00PM (Mountain Time) or send an e-mail to CS@Bacterin.com to obtain a Return Authorization (RA) number.

Device

Device Recall Elutia Surgical Wound Drain
  • 모델명 / 제조번호(시리얼번호)
    19 Fr Round Hubless part number 7110 lot number 016913; 24 Fr Round Hubless part number 7118 lot numbers 028013, 028113 and 028213..
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed to one foreign consignee in Lebanon.
  • 제품 설명
    Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" || Two different sizes, 10 units per box: || 19 Fr Round Hubless part number 7110; || 24 Fr Round Hubless part number 7118. || AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system.
  • 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