Events

Device Recall PureWick External Catheter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Purewick 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
    76571
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1485-2017
  • 사례 시작날짜
    2016-02-24
  • 사례 출판 날짜
    2017-03-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-05-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153554
  • 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
    Bag, urine collection, leg, for external use, non-sterile - Product Code NNW
  • 원인
    Purewick is recalling external catheter for women wicks because the labeling did not contain the phrase "this product contains dry natural rubber" and/or erroneously included the phrase "latex-free." the white gauze component of the purewick contains dry natural rubber.
  • 조치
    A Urgent Medical Device recall letter dated March 2, 2017 will be sent to customers to inform them that PureWick Corporation is recalling specific lots of PureWick external catheter for women Wicks, Item #625. Customers are informed that PureWick is recalling PureWick Wicks because labeling on product shipped prior to February 22, 2017 either did not contain the phrase This product contains dry natural rubber and/or erroneously included the phrase Latex-free. The white gauze component of the PureWick Wick contains dry natural rubber. PureWick Corporation has received zero complaints or reports of adverse events related to the error in labeling. Customers are informed of the risk to health and the actions to be taken. Customers are instructed to complete the enclosed PureWick Field Correction form and fax to PureWick Corporation at (619) 660-5459 or email to response@purewick.com. Customers with questions or would like assistance completing the PureWick Field Correction Form are instructed to call PureWick toll-free at (844) 584-0734 Monday  Friday from 8:00 a.m. to 4:30 p.m., Pacific Time.

Device

Device Recall PureWick External Catheter
  • 모델명 / 제조번호(시리얼번호)
    Item # 625
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US: Nationwide Distribution
  • 제품 설명
    PureWick External Catheter for Women-Wick || Product Usage: || A flexible, contoured external catheter (a Wick) is positioned between the labia and gluteus muscles. The function of the Wick is to draw urine away from the body through the Wick to a storage container away from the body through a PVC tube via a continuous, low pressure vacuum pump (PureWick DryDoc) or to a hospital wall vacuum. There is never a reversal of flow direction or static state of fluid between the device and the patient. Also, the dry natural rubber component is double wrapped with 75D polyester and it is not stretched in its application to expose bare rubber to a user. The Wick does not enter the vagina (Figure 1).
  • Manufacturer
    Purewick Corporation

Manufacturer

Purewick Corporation
  • 제조사 주소
    Purewick Corporation, 2030 Gillespie Way Ste 109, El Cajon CA 92020-0910
  • 제조사 모회사 (2017)
    Purewick Corporation
  • Source
    USFDA