Events

DISPOSASHIELD 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 O'Ryan Industries 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
    61675
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1505-2012
  • 사례 시작날짜
    2012-04-23
  • 사례 출판 날짜
    2012-05-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108697
  • 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
    Activator, ultraviolet, for polymerization - Product Code EBZ
  • 원인
    Disposa-shield disposable curing shield is recalled due to lacking 510k, pma or ide, and inadequate quality system.
  • 조치
    The firm, O'Ryan Industries Inc., began to contact consignees by telephone and sent email on April 25, 2012. O'Ryan sent a recall notification letter dated May 7, 2012 to their customers through the Purchasing Agents and Order Department Personnel. The letter described the product, problem, and actions to be taken by the customers. Customers were advised to return the Disposa-Shield back to O'Ryan Industries. Customers can call O'Ryan Industries at 800-426-4311 or fax to 360-892-6742.

Device

DISPOSASHIELD
  • 모델명 / 제조번호(시리얼번호)
    No serial numbers, no codes, and no expiration dates.
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: USA including states of NC, MN, OR and WI.
  • 제품 설명
    DISPOSA-SHIELD. The Disposable Curing Shield For Your Curing Light. The disposable Disposa-Shield are sold in different sizes from 6 mm, 8 mm, 9 mm, 11 mm and 13 mm. || The devices are Intended to be place over the tip of a dental curing light wand to protect the doctor's and patient's vision from exposure to high intensity light; soften contact of curing light against the teeth, and keep light guide cleaner, therefore maintaining good levels of light intensity for proper and fast curing The label of the O'Ryan Disposa-Shield listed the following: -Protect Doctor's And Patient's Vision From Exposure To High Intensity Light. -Soften Contact Of Light Guide Against Teeth. -Keep Light Guide Cleaner, Therefore, Maintaining Good Levels Of Light Intensity For Proper And Faster Curing. || There are 25 devices per clear plastic bag when distributed in bulk and two devices per clear plastic zip lock type bag when distributed with curing lights. || The "Sterilize Before Use" label is placed on a clear plastic bag containing 25 pieces of Disposa-Shield units distributed with all shipment of bulk Disposa-Shield. || The "Sterilize Before Use" label is NOT placed on plastic zip lock type bag when distributed with two Disposa-Shield with curing lights. || The product is labeled in parts: || "***DISPOSA-SHIELD***The Disposable Curing Shield For Your Curing Light***STERILIZE BEFORE USE***O'RYAN INDUSTRIES***INSTRUCTIONS FOR INSTALLING DISPOSA-SHIELD***1. Remove and dispose of old DISPOSA-SHIELD***2. Sterilize wand tip***3. Simply stretch new DISPOSA-SHIELD over tip of wand***800-426-4311 or (360) 892-0447***(360) 892-6742 Fax***info@oryanindustries.com***'. || The private label is labeled in parts: || "***DISPOSA-SHIELD***The Disposable Curing Shield For Your Curing Light***ALMORE INTERNATIONAL , INC***STERILIZE BEFORE USE***".
  • Manufacturer
    O'Ryan Industries Inc

Manufacturer

O'Ryan Industries Inc
  • 제조사 주소
    O'Ryan Industries Inc, 12711 NE 95th St, Vancouver WA 98682-2412
  • 제조사 모회사 (2017)
    O'Ryan Industries Inc
  • Source
    USFDA