Events

Device Recall Coseal Surgical Sealant. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Baxter Healthcare Services L.P. 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
    59861
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1614-2012
  • 사례 시작날짜
    2011-07-28
  • 사례 출판 날짜
    2012-05-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103883
  • 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
    The recall is being conducted as a precautionary measure due to out of specification results observed at the 24 months time point (out of 24-month licensed shelf life to expiration) during a coseal stability study. the parameter that is out specification is an indicator of possible failure for the product to gel appropriately . coseal's failure to gel does not represent risk for the patient's life.
  • 조치
    Baxter Healthcare sent an"URGENT PRODUCT RECALL" letter dated July 27, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to immediately stop the usage/distribution of the affected product and to quarantine any units that are in inventory. Instructions for obtaining replacement product were attached to the letter. Contact the firm at 1-800-423-2090 for questions concerning this recall.

Device

Device Recall Coseal Surgical Sealant.
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: (2mL) HA100143, HA091236. (4mL) HA090950, HA090944, HA090843, HA090749, HA090947. (8mL) HA100132, HA100142
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Coseal Surgical Sealant. || Coseal is an adjunctive surgical sealant.
  • Manufacturer
    Baxter Healthcare Services L.P.

Manufacturer

Baxter Healthcare Services L.P.
  • 제조사 주소
    Baxter Healthcare Services L.P., 1 Baxter Pkwy, Building 3, Deerfield IL 60015-4625
  • 제조사 모회사 (2017)
    Baxter International
  • Source
    USFDA