Events

AV-Set B DT INF-E Blood Tubing System 의 안전성 경고

Food and Drug Administration Philippines에 따르면, 해당 안전성 경고 는 Philippines 에서 N/A 에 의해 제조된 제품과 관련되어 있습니다.

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안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 연번
    2017-329
  • 사례 국가
    Philippines
  • 사례 출처
    FDAP
  • 사례 출처 URL
    https://ww2.fda.gov.ph//index.php/advisories-2/medical-devices-advisories-pertaining-to-all-regulated-medical-devices/481106-fda-advisory-no-2017-329
  • 비고 / 경고
    Data from the Philippines is current through 2019. All of the data comes from the Food and Drug Administration Philippines, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Philippines.
  • 데이터 추가 비고
  • 원인
    Fda advisory no. 2017-329 voluntary recall of  av-set b dt inf-e blood tubing system with dvr no. 8574 (article no. ap16641) all are hereby advised by the food and drug administration (fda) about the voluntary recall of the following batches of av-set b dt inf-e blood tubing system (see figures 1 and 2) with dvr no. 8574. the said products were imported and distributed by fresenius medical care philippines, inc. with office address at chino roces avenue, makati city. product name:   av-set b dt inf-e blood tubing system certificate of registration number:  dvr-8574 article no. : ap16641   batch number   batch number   batch number 1 ybc132 18 ygc142 35 ybc144 2 ycc092 19 ygc152 36 ybc153 3 ydc262 20 ybc181 37 ybc181 4 ydc271 21 ycc043a 38 ycc032 5 ydc282 22 ycc122 39 ycc043a 6 ydc301 23 ycc301 40 ycc081 7 yec013 24 ydc012 41 ycc092 8 yec031 25 ydc262 42 ycc122 9 yec053 26 ydc271 43 ydc011 10 yec294 27 ydc282 44 ydc262 11 yfc012 28 ydc301 45 ydc271 12 yfc023 29 yec013 46 ydc282 13 yfc091 30 yec031 47 ydc301 14 yfc103 31 yec053 48 yec013 15 yfc113 32 yec063 49 yec031 16 ygc102 33 yec294 50 yec053 17 ygc131 34 ybc132 *nothing follows* the above-stated medical device products are being voluntary recalled by fresenius medical care philippines, inc. because small clamps located at pre-pump position of t connector and post-pump positions of arterial and venous chamber may not close properly and could in some cases lead to blood leakage during treatment. distributors, retailers, hospitals and all healthcare professionals/users are advised to discontinue further distribution, sale and use of the said affected medical device product. any suspected adverse reaction experienced from the use of the device but not limited to the lot stated above, should be reported immediately to fda at telephone number (02) 857-1900 local 8301 or email us at this email address is being protected from spambots. you need javascript enabled to view it. . dissemination of the information to all concerned is requested. attachments: fda advisory no. 2017-329.Pdf.

Device

AV-Set B DT INF-E Blood Tubing System
  • 모델명 / 제조번호(시리얼번호)
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    FDAP