Device Recall Pulset Arterial Blood Gas (ABG) sampling kit. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Westmed 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
    63276
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0104-2013
  • 사례 시작날짜
    2011-01-18
  • 사례 출판 날짜
    2012-10-20
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-10-22
  • 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
    Arterial blood sampling kit - Product Code CBT
  • 원인
    Westmed is recalling westmed abg convenience kits containing triad brand alcohol pads because triad is recalling triad brand alcohol pads due to potential contaminants.
  • 조치
    Westmed sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 18, 2011 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were also given the TRIAD GROUP: "Urgent Drug Recall" and "Facts: Alcohol Recall" both dated January 3, 2011. Westmed customers were instructed to remove the TRIAD alcohol pad from the kit and dispose of the alcohol pad only. Customers were instructed to complete and return the enclosed response form as soon as possible. Customers with questions were instructed to contact the firm at (520) 264-7987 x1233.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 38941, 39213, 40203, 41694, 42317, 42700, 43129, 43195, 43502, 44695, 45065, 45254, 45919, 46776, 47369, 4669149785.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) and the countries of Canada, El Salvador, United Arab Emirates, Holland, Costa Rica and Lebanon.
  • 제품 설명
    Pulset Arterial Blood Gas (ABG) sampling kit. || Full Kit, Pulset, 3 cc, 22 g x 1" A/B Needle, 25U Balanced Heparin, part number: 3372. || An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Westmed Inc, 5580 S Nogales Hwy Ste 170, Tucson AZ 85706-3333
  • 제조사 모회사 (2017)
  • Source
    USFDA