Events

Device Recall Stylus Brand Angled Knives 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Surgical Specialties Puerto Rico, 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
    28948
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0947-04
  • 사례 시작날짜
    2004-03-03
  • 사례 출판 날짜
    2004-07-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2004-09-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32923
  • 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
    Knife, Ophthalmic - Product Code HNN
  • 원인
    Incorrect placement of the blade in the foam of product results in blade poking through packaging. compromised sterility and injury to healthcare worker.
  • 조치
    Customers were notified by e-mail and fax of the recall during the period of March 3, 2004 to April 1, 2004. Customers were requested to return the product to Surgical Specialties Corporation, Reading, PA 19606.

Device

Device Recall Stylus Brand Angled Knives
  • 모델명 / 제조번호(시리얼번호)
    Model No. Lot # Exp.date 52-2661 M309600 5/2008 52-2662 M309610 8/2008 52-2661 M309620 8/2008 52-2661 M309630 8/2008 52-2661 M264510 3/2008 52-2761 M436360 12/2008 52-2761 M309720 9/2008 52-2761 M309730 9/2008 52-2761 M365020 10/2008 52-2761 M365030 11/2008 52-2861 M309770 5/2008 52-2861 M309780 7/2008 52-2861 M430490 12/2008 52-2861 M437160 1/2009 52-2861 M439540 1/2009 52-2861 M309790 8/2008 52-2861 M309810 9/2008 52-2961 M376790 8/2008 52-2961 M309860 6/2008 52-2961 M309870 7/2008 52-2961 M416990 10/2008 52-3261 M440600 2/2009 52-3261 M262580 3/2008 52-3261 M309940 7/2008 52-3261 M309960 8/2008 52-3261 M309970 8/2008 52-3561 M311070 4/2008 52-2662 M445610 2/2009 52-3262 M280120 3/2008
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distribution was nationwide and internationally
  • 제품 설명
    Stylus Brand Angled Knife - 52-2661, Slit Knife, bevel up, angled full handled, 2.65mm || 52-2761, Slit Knife, bevel up, angled, full handled, 2.75mm || 52-2861, Slit Knife, bevel up, angled, full handled, 2.85mm || 52-2961, Slit Knife, bevel up, angled, full handled, 3.0mm || 52-3261, Slit Knife, bevel up, angled, full handled, 3.2mm || 52-3561, Slit Knife, bevel up, angled, full handled, 3.5mm || 52-2662, Slit Knife, bevel up, angled, blade and tip, 3.2mm || 52-3262, Slit Knife, bevel up, angled, blade and tip, 3.2mm
  • Manufacturer
    Surgical Specialties Puerto Rico, Inc.

Manufacturer

Surgical Specialties Puerto Rico, Inc.
  • 제조사 주소
    Surgical Specialties Puerto Rico, Inc., Road 115 Km.12.9, Rincon PR 00677
  • Source
    USFDA