Events

Device Recall ProWick Shoulder Postoperative Dressing and Cold Therapy System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Integra Biotechnical 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
    37358
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0714-2007
  • 사례 시작날짜
    2007-02-01
  • 사례 출판 날짜
    2007-04-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50412
  • 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
    Postoperative Dressing and Cold Therapy System - Product Code FRO
  • 원인
    During routine new product testing, it was discovered that the product may not be sterile, although sterilized in accordance with validated parameters.
  • 조치
    An email and/or fax recall notification was sent starting on 02/1/2007 by Arthrex, Inc. (the Primary Distributor) . A product recall notice in the form of a letter was mailed via US Postal Certified Mail, return receipt requested by Arthrex, Inc. to all of the Distributor''s customers starting on 02/1/2007, including those who have not ordered or received the Recalled Product. Customers were asked to 'segregate and protect the product from shipment, and return all unused products to Arthrex, Inc.'

Device

Device Recall ProWick Shoulder Postoperative Dressing and Cold Therapy System
  • 모델명 / 제조번호(시리얼번호)
    Lot number: D632517
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Nationwide
  • 제품 설명
    ProWick Shoulder Postoperative Dressing and Cold Therapy System, Model number AR-1625
  • Manufacturer
    Integra Biotechnical LLC

Manufacturer

Integra Biotechnical LLC
  • 제조사 주소
    Integra Biotechnical LLC, 2755 Dos Aarons Way, Ste B, Vista CA 92081
  • Source
    USFDA