Events

Device Recall COSEAL Surgical Sealant 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Baxter Healthcare Corp 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
    74139
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1839-2016
  • 사례 시작날짜
    2016-05-12
  • 사례 출판 날짜
    2016-05-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146452
  • 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
    Sealant,polymerizing - Product Code NBE
  • 원인
    Potential for incomplete dissolution of the polyethylene glycol (peg) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use.
  • 조치
    An Urgent Product Recall letter dated 5/13/16 was sent to customers to inform them that Baxter Healthcare Corporation is issuing a voluntary product recall for the product codes and lots listed below due to the potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use. The letter provides the customers with the list of affected products, hazards involved, and actions to be taken. Customers with questions regarding the recall communication, are instructed to contact Baxter Product Surveillance at (800) 437-5176, 8-5pm, Monday-Friday.

Device

Device Recall COSEAL Surgical Sealant
  • 모델명 / 제조번호(시리얼번호)
    HA160151, HA151205, HA151036, HA151035, HA160229
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.
  • 제품 설명
    COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
  • Manufacturer
    Baxter Healthcare Corp

Manufacturer

Baxter Healthcare Corp
  • 제조사 주소
    Baxter Healthcare Corp, 21026 Alexander Ct, Hayward CA 94545-1234
  • 제조사 모회사 (2017)
    Baxter International
  • Source
    USFDA