Device Recall MEDLINE ADULT MANUAL RESUSCITATOR 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sun Med, LLC 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
    80201
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2152-2018
  • 사례 시작날짜
    2018-05-24
  • 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
    Ventilator, emergency, manual (resuscitator) - Product Code BTM
  • 원인
    There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. this may impact air delivery to the patient.
  • 조치
    On May 25, 2018 Sun Med, LLC issued URGENT MEDICAL DEVICE PRODUCT REMOVAL notices to two of their customers. On June 1, 2018 Sun Med, LLC issued a press release. Customers were encouraged to take the following actions: 1) Examine inventory, quarantine and cease distribution of impacted product. 2) If customers further distributed product, please identify your customers/consignees and notify them of this product removal. Your notification may be enhanced by including a copy of the removal notice. If you need any assistance contacting your customers, please inform SunMed. 3) Complete and return the Removal Return Response Form via fax to 1-800-400-8820 or via email to info@sun-med.com as soon as possible. 4) Once you return the affected product(s), new corrected replacement resuscitation bags will be provided to you. If you need replacement products to be sent to you urgently, please call SunMed directly. Customers with questions can call 1-800-433-2797 or email info@sun-med.com

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 313546, 313717, 313176 & 313772
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    IL & OH distributors
  • 제품 설명
    MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, TUBE RESERVOIR AND 7 FT. OXYGEN TUBING, REF CPRM1126
  • Manufacturer

Manufacturer

  • 제조사 주소
    Sun Med, LLC, 2710 Northridge Dr NW Ste A, Grand Rapids MI 49544-9112
  • Source
    USFDA