HARVEST(R) TERUMOBCT, BMAC3007 Bone Marrow Procedure Pack 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Terumo BCT, 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
    78307
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0103-2018
  • 사례 시작날짜
    2017-10-20
  • 사례 상황
    Open, Classified
  • 사례 국가
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Centrifuges (micro, ultra, refrigerated) for clinical use - Product Code JQC
  • 원인
    The patient labels included in the bmac system procedure packs, catalog numbers 51416 and 51423, are printed with an incorrect lot number, catalog number, and expiry date; the lot number on the procedure pack box label is correct. the expiration noted was not beyond initiation date of the recall. since the product is noted as sterile, the clearance for k103340, k052925 and k991430 raises question if product was cleared with a sterility claim. further post-market follow-up will be required to assess the safety risk of the product.
  • 조치
    The firm initiated their recall by letter on 10/20/2017. The letter stated the following: "ACTIONS REQUIRED FOR HEALTHCARE PROVIDERS AND DISTRIBUTORS 1. For product shelved in the original procedure pack (white box), examine the label for catalog/lot numbers as shown in Figure C above. 2. If affected product is in your inventory, contact the Terumo BCT Customer Support Center at +1.877.3.FYI.BCT (U.S. Toll-Free +1.877.339.4228) or +1.303.231.HELP (+1.303.231.4357), Terumo BCT Europe N.V. at +32.2.715.0590, or your local Terumo BCT representative, and Terumo BCT will issue a Return Goods Authorization for product return. 3. Continue to use your unaffected product in accordance with the instructions for use. 4. Distribute this notification to all Harvest Bone Marrow Aspirate Concentrate (BMAC) System users within your organization. 5. IMPORTANT: Complete the attached acknowledgement and return it by fax or email to Terumo BCT by 27 October 2017. Your return of the acknowledgement is critical so we can confirm that you have received the recall notice.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot 04A9938
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    CA, Co, MO, NY, PA, TX, VA, WI, Turkey, Austria, Spain
  • 제품 설명
    HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO
  • Manufacturer

Manufacturer

  • 제조사 주소
    Terumo BCT, Inc., 10811 W Collins Ave, Lakewood CO 80215-4440
  • 제조사 모회사 (2017)
  • Source
    USFDA