Events

Device Recall CareFusion Wet PVPI Small Procedure Preoperative Skin Prep Tray 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Carefusion 2200 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
    61103
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1207-2012
  • 사례 시작날짜
    2012-02-07
  • 사례 출판 날짜
    2012-03-14
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-06-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107303
  • 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
    Skin prep tray (kit) - Product Code OJU
  • 원인
    The povidone-iodine (pvp-i) solution bottles in the trays may have loose caps, allowing leakage and also elevated levels of ethylene oxide (eo) sterilant and/or by-products within the pvp-i solution, which may represent a patient safety hazard.
  • 조치
    CareFusion sent e-mails and follow-up Urgent Recall Notices dated February 7, 2012 to all of the affected customers on the same date, requesting that the customers follow the steps outlined below as mitigation until product can be replaced. 1. Please immediately destroy/discard or return any affected product you may have in-stock at your facility. Do NOT further distribute these products. 2. Forward this RECALL NOTICE to any customers to whom these products were sold notifying them of the potential risk (reference attachment for affected production lot numbers). End users must be advised to discard or return any CareFusion Skin Prep Tray with the noted product/lot number; distributors should manage this return process per their internal procedures. End users MUST NOT use these products. 3. Complete and return the attached Acknowledgement Form indicating that they have received this RECALL NOTICE and that they will communicate the Recall Notice to all customers who have purchased CareFusion Preoperative Skin Prep Tray catalog numbers 4420, 4468, and 4469A. 4. Contact CareFusion Customer Service at (800) 523-0502 ext. 53576 for details on return and/or replacement of stock.

Device

Device Recall CareFusion Wet PVPI Small Procedure Preoperative Skin Prep Tray
  • 모델명 / 제조번호(시리얼번호)
    tray catalog number 4420. tray lot numbers 0000319389, 0000321446, 0000323733, 0000326090, 0000328468, 0000330882, 0000333747, 0000336418, 0000336443, 0000340606, 0000344792, 0000349464, 0000354078, 0000354079, 0000358785, 0000367470, Y11Cl711, Y11C2202, Y11C3733, Y11C3751, Y11D0544
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including Arizona, California, Colorado, Connecticut, Florida, Illinois, Missouri, Nebraska, Nevada, New York, Ohio, Puerto Rico, Rhode Island, South Carolina, South Dakota, Texas, Utah and Virginia.
  • 제품 설명
    Wet PVP-I Small Procedure Preoperative Skin Prep Tray containing 1 - 59 mL bottle Povidone Iodine Cleansing Solution (Scrub) USP 7.5% and 1 - 59 mL bottle Povidone Iodine Topical Solution (Paint) USP 10% with Powder-Free Esteem Gloves; 20 trays per case; a sterile, latex-free, single use only tray, solution not exposed to sterilant; U.S. components packaged in Mexico except as indicated: Gloves and Cotton-Tipped Applicators made in China, Sponge Stick made in Mexico; CareFusion, McGaw Park, IL 60085 USA; tray catalog number 4420 || The Povidone Iodine patient prep trays are used where chlorhexidine gluconate (CHG) products aren't appropriate or indicated for patient preoperative prep (traditional two-step scrub and paint using cleansing solution and topical solution) on intact skin and mucous membranes, and for washing lacerations and abrasions.
  • Manufacturer
    Carefusion 2200 Inc

Manufacturer

Carefusion 2200 Inc
  • 제조사 주소
    Carefusion 2200 Inc, 1500 Waukegan Rd, Mpwm Bldg., McGaw Park IL 60085-6728
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA