Events

Device Recall Converters(R) Under Buttocks Drape with Fluid Control Pouch II, 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cardinal Health 200, LLC 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
    77686
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2757-2017
  • 사례 시작날짜
    2017-06-27
  • 사례 출판 날짜
    2017-07-07
  • 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=157504
  • 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
    Drape, surgical - Product Code KKX
  • 원인
    Outer label of some units of product number/lot number 8482, lot 16lfs235 and product number/lot number 9414, lot 16lus317 do not match the drape packaged inside.
  • 조치
    Cardinal Health sent an Urgent Product Recall letter dated June 27, 2017, to all affected consignees. In the letter, the firm requested the following actions be taken: 1. Inspect your inventory for the affected product code and lot number (listed on the package) 2. segregate and quarantine all on-hand product 3. Return the enclosed acknowledgment form via fax to 847-689-9101 ir614-652-9648, whether or not you have affected product, indicating the product code, lot and quantity of product you've quarantined or discarded. 4. Notify any customers to whom may have distributed or forwarded product affected by this product. 5. Contact the appropriate Customer Service group to arrange for return and credit of any affected product: Hospital - 800-964-5227 Federal Government - 800-444-1166 Distributor - 600-635-6021 All other customers - 888-444-5401 For questions regarding this recall call 800-327-7503.

Device

Device Recall Converters(R) Under Buttocks Drape with Fluid Control Pouch II,
  • 모델명 / 제조번호(시리얼번호)
    Lot 16LFS235, expires November 1, 2021
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (Nationwide including PR) and Canada
  • 제품 설명
    Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, Qty. 1, Cardinal Health, Waukegan, IL || A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
  • Manufacturer
    Cardinal Health 200, LLC

Manufacturer

Cardinal Health 200, LLC
  • 제조사 주소
    Cardinal Health 200, LLC, 1500 S Waukegan Rd, Waukegan IL 60085-6728
  • 제조사 모회사 (2017)
    Cardinal Health
  • Source
    USFDA