Events

Device Recall Overpressure Safety Valve 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Terumo Cardiovascular Systems Corporation 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
    78546
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0256-2018
  • 사례 시작날짜
    2017-06-27
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159745
  • 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
    Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass - Product Code DTL
  • 원인
    Terumo cardiovascular systems (terumo cvs) has received reports of no flow through the over-pressure safety (ops) valve.
  • 조치
    The firm sent a safety alert to its consignees on 07/27/2017 by mail. The notice requested that the consignee test the product prior to using. If the product did not operate, the consignee was asked to return it. Beginning on 12/11/2017 the firm conducted a removal by mail of any remaining product. The customer instructions are as follows: CUSTOMER INSTRUCTIONS Review this Medical Device Recall Notice. Assure that all users receive notice of this issue. Refer to the Customer Response Form to identify your product that is subject to this action. Confirm receipt of this notification by completing and returning the attached Customer Response Form to the email address or fax number indicated on the form . Terumo CVS will issue a Returned Goods Authorization upon receipt of the Customer Response Form. Return all affected products to Terumo CVS. QUESTIONS? We encourage you to contact Terumo CVS with any questions or concerns: Terumo CVS Customer Service: 1.800.521.2818 Monday- Friday, 8 a.m . - 6 p.m. ET Terumo Safety Alert Fax: 1.410.392.7183 Terumo Safety Alert Email: TCVSCustomerResponseElkton@terumomedical.com

Device

Device Recall Overpressure Safety Valve
  • 모델명 / 제조번호(시리얼번호)
    SAFETY ALERT Lot Codes:  (a) RH14, RK11, RK20, RL02, RM06, RM20, RN10, RP08, TD16, TE13, TE27, TF14, TF21, TG04, TG11, TG17, TH06, TH16, TK10, TK24, TL08, TL21, TM28, TP14, UA11, UA18, UA25, UC08, UC22, UD14, UD21, UD28, UE05, UE18, UF09, UG06, UK01, UL12, UM10, UM31, UP05, VA02, VC06, VD06, VE10    (b) RH14, RH21, RK18, RL15, RM01, RM22, RN24, RP01, TA19, TF05, TF27, TG19, TH20, TK24, TL01, TM12, TN09, TP03, UA20, UC15, UD22, UE04, UE18, UF02, UG13, UH11, UK15, UL06, UM10, VA02, VA30, VC27, VE03, VF01   LH130 PRODUCT CORRECTION lot codes or serial number range: TA19 through VD06, distribution date range: 08Apr2015 through 20Jan2017
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: US, Canada, Colombia, UK, Belgium, and Japan
  • 제품 설명
    TERUMO(R) Overpressure Safety Valve, REF: (a) LH130 (b) LH130J
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • 제조사 주소
    Terumo Cardiovascular Systems Corporation, 125 Blue Ball Rd, Elkton MD 21921-5315
  • 제조사 모회사 (2017)
    Terumo Corp.
  • Source
    USFDA