Events

DuraGuard Dural Repair Patch 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Synovis Surgical Innovations, 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
    66763
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0339-2014
  • 사례 시작날짜
    2013-10-28
  • 사례 출판 날짜
    2013-11-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-06-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123332
  • 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
    Dura substitute - Product Code GXQ
  • 원인
    Synovis, a subsidiary of baxter international inc., is recalling certain shipments of vascuguard and dura-guard because synovis, a subsidiary of baxter international inc., is recalling certain shipments of vascuguard and dura-guard because the shipping configurations in which the 6 fluid ounce units containing a specific revision of the instructions for use (ifu) shipped in a divided cell shipping.
  • 조치
    A customer notification letter dated 10/28/13 was sent to all customers who purchased the Vascu Guard and the Dura Guard. The letter informs the customers of the problem identified and the actions to be taken. Customers with any questions regarding the recall are instructed to contact Customer Service unit at (800) 423-2090. If customers are distributors or if they have have distributed the recalled products to any other health care provider, they are instructed to notify their accounts and provide them with a copy of the recall notification. If customers would like Baxter to perform the recall task for them, then they are instructed to contact Stericycle at 1-866-912-8417.

Device

DuraGuard Dural Repair Patch
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers:  SPCE113-03C0006 SPCE113-04D0002 SPCE113-04D0047 SPCE113-05E0052 SPCE113-05E0072 SPCE113-07G0077 SPCE113-08H0018 SPCE113-08H0073 SPCE113-03C0008 SPCE113-03C0072 SPCE113-04D0036 SPCE113-04D0092 SPCE113-04D0093 SPCE113-05E0047 SPCE113-05E0048 SPCE113-06F0053 SPCE113-06F0054 SPCE113-07G0008 SPCE113-07G0072 SPCE113-08H0016 SPCE113-FEB0092 SPCE113-JAN0046 SPCE113-JAN0106 SPCE113-03C0004 SPCE113-03C0069 SPCE113-03C0070 SPCE113-03C0071 SPCE113-04D0085 SPCE113-04D0086 SPCE113-05E0073 SPCE113-05E0074 SPCE113-06F0055 SPCE113-06F0057 SPCE113-06F0138 SPCE113-06F0139 SPCE113-07G0074 SPCE113-07G0075 SPCE113-08H0019 SPCE113-JAN0047 SPCE113-JAN0048 SPCE113-JAN0109 SPCE113-JAN0125
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Dura Guard, Dural Repair Patch with Apex Processing. || For use as a dura substitute for the closure of dura mater during neurosurgery. || Product Code: || DG0209SN || DG0209SN || DG0209SN || DG0209SN || DG0209SN || DG0209SN || DG0209SN || DG0209SN || DG0404SN || DG0404SN || DG0404SN || DG0404SN || DG0404SN || DG0404SN || DG0404SN || DG0404SN || DG0404SN || DG0404SN || DG0404SN || DG0404SN || DG0404SN || DG0404SN || DG0404SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN || DG0608SN
  • Manufacturer
    Synovis Surgical Innovations, Inc.

Manufacturer

Synovis Surgical Innovations, Inc.
  • 제조사 주소
    Synovis Surgical Innovations, Inc., 2575 University Ave W, Saint Paul MN 55114-1073
  • 제조사 모회사 (2017)
    Baxter International
  • Source
    USFDA