Events

Device Recall MEDLINE SIRUS Surgical Gown, Strong Protection Surgical Gown, Surgeon 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Master & Frank (Pinghu) Co., Ltd. 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
    77633
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3079-2017
  • 사례 시작날짜
    2017-06-01
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156974
  • 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
    Gown, surgical - Product Code FYA
  • 원인
    The sleeve seam of the breathable material was found to have inconsistent sealing, which has the potential to allow fluid to flow pass through the protective seam.
  • 조치
    Master & Frank Enterprise Co., LTD is working directly with Medline Industries, Inc., on this recall. A written notification was emailed to Medline Industries, Inc. on June 1, 2017 notifying them of the recall and further instructions. Consignee was instructed to quarantine and destroy any recalled product and to respond to the recall communication. The attached recall response form requested that the consignee notify all of their own customers of the recall.

Device

Device Recall MEDLINE SIRUS Surgical Gown, Strong Protection Surgical Gown, Surgeon
  • 모델명 / 제조번호(시리얼번호)
    Reference No. DYNJP2229S; Lot/Serial No. 45016070513PH
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Domestic: IL.
  • 제품 설명
    MEDLINE SIRUS Surgical Gown, Strong Protection, Poly-Reinforced, Breathable Film Sleeve, XXL-XLONG Sterile Single-Use Gown; Sold in kit with Sterile Gown/Hand Towel/CSR Wrap and boxes of 18 Gowns.
  • Manufacturer
    Master & Frank (Pinghu) Co., Ltd.

Manufacturer

Master & Frank (Pinghu) Co., Ltd.