Events

Doyle AbsorbENT Nasal Pack w/airway & string 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Summit Medical, 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
    72276
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0435-2016
  • 사례 시작날짜
    2015-09-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-05-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140459
  • 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
    Applicator, ent drug - Product Code LRD
  • 원인
    Summit medical is recalling doyle p/f nasal pack w/airway, string 8 cm x 3 cm x 1.5 cm, catalog # rh-7413-10, lot # 160889 & 161354 because the product does not have the split in the packing.
  • 조치
    Consignees were sent a Summit Medical "Medical Device Recall" letter, dated September 2, 2015. The letter described the problem and the product involved in the recall. It also advised consignees to immediately examine their inventory, quarantine the product, and to complete the attached response form, as well as follow the instructions provided regarding the affected product. For questions, contact Nicole Dove at 651-789-3921 or ndove@summitmedicalusa.com.

Device

Doyle AbsorbENT Nasal Pack w/airway & string
  • 모델명 / 제조번호(시리얼번호)
    160889, 161354
  • 의료기기 분류등급
    Ear, Nose, and Throat Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distributed to CA.
  • 제품 설명
    AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx only. || Used as a nasal packing following intranasal surgery to absorb blood and other fluids in the nasal cavity.
  • Manufacturer
    Summit Medical, Inc.

Manufacturer

Summit Medical, Inc.
  • 제조사 주소
    Summit Medical, Inc., 815 Northwest Pkwy Ste 100, Eagan MN 55121-1658
  • Source
    USFDA