Device Recall ARROW MultiLumen Central Venous Catheterization Set with Blue FlexTip Catheter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Arrow International 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
    80227
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2336-2018
  • 사례 시작날짜
    2018-05-11
  • 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
    Catheter, percutaneous - Product Code DQY
  • 원인
    The recalling firm has received complaints related to increased resistance encountered when introducing the cvc over the spring wire guide. this may lead to procedural delay, and there may be need of medical intervention by exchanging the catheter for another cvc catheter.
  • 조치
    On May 11, 2018, the firm sent an Urgent Medical Device Recall letter to affected customers via FedEx. Distributors were instructed to take the following actions: 1. Immediately discontinue distribution and quarantine any products with the product code and lot number listed above. 2. Using the provided customer letter and Recall Acknowledgement Form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. 3. Have the customers return any affected product to you, together with a completed Recall Acknowledgement Form, for consolidation and return to Arrow International. In the event that an alternative approach is needed, contact Arrow International Customer Service for more information at 1-866-396-2111. 4. To return affected products from your inventory, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Arrow International. 5. Once you have completed returning all of the recalled products from your own inventory, and collecting and consolidating all of the recalled products from your customers, please check the box on the enclosed Recall Acknowledgment Form that indicates that you have completed the recall and fax it to 1-855-419-8507, Attn: Customer Service, or email it to recalls@teleflex.com. This will allow us to document completion of the recall. 6. If you and your customers have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document your receipt of this letter.

Device

  • 모델명 / 제조번호(시리얼번호)
    71F18A0682
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributor in FL. International distribution to Czech Republic, Dominican Republic, France, Greece, and Italy.
  • 제품 설명
    Multi-Lumen Central Venous Catheterization Set with Blue FlexTip Catheter, CS-15853-E || Product CVCs are intended to permit venous access to the central circulation through a single puncture site by way of the femoral, jugular, or subclavian veins.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • 제조사 모회사 (2017)
  • Source
    USFDA