Events

Device Recall Oasis Corneal Ink Stamp Sterile 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Aspen Surgical Products, 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
    57792
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1335-2011
  • 사례 시작날짜
    2010-12-23
  • 사례 출판 날짜
    2011-02-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-10-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97448
  • 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
    Corneal Marking Pad - Product Code HMR
  • 원인
    Fragments from the pad may disengage and stick to the instrument. the condition could cause fragments to come into contact with the intact cornea prior to surgery.
  • 조치
    Aspen Surgical sent URGENT MEDICAL DEVICE RECALL NOTICES dated 12/23/2010 by Certified Mail. The letters instructed the users to examine their inventory and place the recalled products in quarantine. Consignees were instructed to return the product and complete the response form. Distributors were asked to notify their customers or requesting that Aspen notify the customers. The firm does not intend to continue manufacturing or distributing the product.

Device

Device Recall Oasis Corneal Ink Stamp Sterile
  • 모델명 / 제조번호(시리얼번호)
    163346, 163381, 1663384.
  • 의료기기 분류등급
    Ophthalmic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution including USA Canada, England, Sweden, Saudi Arabia, England, Hong Kong, Belgium and Israel.
  • 제품 설명
    Oasis Corneal Marking Pad, REF 0441, Rx only, Sterile. For use in ophthalmic surgery.
  • Manufacturer
    Aspen Surgical Products, Inc.

Manufacturer

Aspen Surgical Products, Inc.
  • 제조사 주소
    Aspen Surgical Products, Inc., 6945 Southbelt Dr Se, Caledonia MI 49316-7664
  • 제조사 모회사 (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA