Events

Device Recall Baxter BURETROL Solution Set 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Baxter Healthcare Corp 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
    68843
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2613-2014
  • 사례 시작날짜
    2014-07-14
  • 사례 출판 날짜
    2014-09-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-03-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128840
  • 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
    Set, administration, intravascular - Product Code FPA
  • 원인
    Baxter healthcare corporation is voluntarily issuing a recall for specific lots of buretrol solution set product codes due to complaints for separation between the burette chamber and the drip chamber. affected product codes are: 2c7564, 2c8864 and 2h8864.
  • 조치
    Action to be taken if product was purchased directly from Baxter: Baxter is requesting that you take the following actions: 1. Locate and remove all affected product from your facility (the product code and lot number can be found on the individual product package or shipping carton). 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. The Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your Baxter eight-digit ship-to account number ready when calling. 3. Complete the enclosed customer reply form, and return it to Baxter by either fax Or scanned e-mail. 4. If you are a dealer, wholesaler, or distributor/reseller that distributed any product to other facilities, please conduct a recall with your end-user customers in accordance with your customary procedures. Baxter distributed this product to customers between September 27, 2013, and April 25, 2014. Action to be taken if the products were purshased from a distributor or re-seller. 1. Locate and remove all affected product from your facility (the product code and lot number can be found on the individual product package or shipping carton). 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. The Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your ship-to account number ready when calling. 3. Follow your supplier's reply and recall process. Please do not return the customer reply form to Baxter.

Device

Device Recall Baxter BURETROL Solution Set
  • 모델명 / 제조번호(시리얼번호)
    2C7564- Buretrol Solution Set with 150mL INTERLINK Burette, lots: DR13E06019 DR13E07017 DR13E07025 DR13I14023 DR13I16010 DR13I16028 DR13I23016 DR13I23024 DR13J03033 DR13J04015 DR13J04023 DR13J08024 DR13J09014 DR13J09022 DR13J24021 DR13J24039 DR13K07024 DR13K08022 DR13K12024 DR13K13022 DR13K18021 DR13K19029 DR13K25026 DR13K26024 DR13L02023 DR13L03039 DR13L10018 DR13L11016 DR13L18011 DR13L18029 DR13L19035 DR14A09052 DR14A10035 DR14A23012 DR14A23020 DR14A29027 DR14A30017 DR14B06049 DR14B07013 DR14B07047 DR14B11023 DR14B13037 DR14B13045 DR14B14019 DR14B20016 DR14B20032 DR14B21014 DR14B26013 DR14B26039 DR14C05015 DR14C05031
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    ***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Chamber Filter Valve***3 Injection Sites || Male Luer Lock Adapter with***Retractable Collar***Fluid path is Sterile, Nonpyrogenic***Indications for Use: For the administration of fluids from a container into the patient's vascular system through a vascular access device.***
  • Manufacturer
    Baxter Healthcare Corp

Manufacturer

Baxter Healthcare Corp
  • 제조사 주소
    Baxter Healthcare Corp, 1 Baxter Pkwy, Deerfield IL 60015-4625
  • 제조사 모회사 (2017)
    Baxter International
  • Source
    USFDA