Events

Device Recall Dynarex brand 100 Sheer Plastic Spot Bandages 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Dynarex Corporation 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
    29031
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0951-04
  • 사례 시작날짜
    2004-05-10
  • 사례 출판 날짜
    2004-07-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33001
  • 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
    Bandage, Elastic - Product Code FQM
  • 원인
    Bandages labeled as "100% latex free" may contain latex. the wrapper was analytically tested by a private laboratory and found to contain latex.
  • 조치
    Recall letters & response forms were sent to the consignees on 5/10/04 via Certified Mail, Return Receipt Requested. On 5/24/04, a second recall letter & response form were mailed via Certified Mail to the 60 distributors that received the 2 additional lots being recalled.

Device

Device Recall Dynarex brand 100 Sheer Plastic Spot Bandages
  • 모델명 / 제조번호(시리얼번호)
    Lot 15860 (recall letter 5/07/04). UPDATE: Lots 15901 & 15706 (recall letter 5/20/04)
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Medical supply distributors located in NY, NJ, PA, TX, MN, GA, FL, MI, OH, IL, MS, KY, AZ , CA, NV, CO, and Puerto Rico, for further distribution to their customers. --- UPDATE: There were 2 foreign accounts in Panama that received the additional lots. The additional lots were distributed to the aforementioned states plus the following states: MA, MO, ME, VA, NC, LA.
  • 제품 설명
    100 Sheer Plastic Spot Bandages, 7/8" Dia. (22 mm). Reorder No. 3607. Manufactured for dynarex Corporation, Orangeburg, NY 10962. Sterile with non-stick pad. 100% Latex Free Bandage & Wrapper. 48 boxes of 100 bandages per case. --- || Device Listing # E177598. 510(k) Exempt.
  • Manufacturer
    Dynarex Corporation

Manufacturer

Dynarex Corporation
  • 제조사 주소
    Dynarex Corporation, 10 Glenshaw Street, Orangeburg NY 10962-1207
  • Source
    USFDA