Events

Device Recall Ansell Sandel Weighted Safety Scalpel 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ansell Sandel Medical Industries 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
    67005
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0639-2014
  • 사례 시작날짜
    2013-11-12
  • 사례 출판 날짜
    2014-01-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-04-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124495
  • 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
    Handle, scalpel - Product Code GDZ
  • 원인
    Select lots of sandel weighted safety scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury.
  • 조치
    The firm, Ansell, sent an "URGENT: VOLUNTARY RECALL OF ANSELL SANDEL WEIGHTED SAFET SCALPEL" letter dated November 11, 2013 to its customers and posted a website notification on November 11, 2013. The letter described the product, problem and actions to be taken. The customers were instructed: Do not ship SANDEL Weighted Safety Scalpel products 2210-L, 2210-N, 2211-L, 2211-N, 2215-L, 2215-N, or 2220-N to a hospital or end user with the listed lot numbers; quarantine SANDEL Weighted Safety Scalpel products in your inventory; and complete the attached response form and return it to attention: Ansell; via fax at 818-534-2510 or email sandel-cs@ansell.com. Additionally, if you have distributed this product to other accounts, please notify them of the voluntary recall and instruct them to return any outstanding stock to you as indicated in the attachment. If you have any questions or need additional information, please contact Customer Service by calling 866-764-3327 (6:00am-5:00pm PST/9:00am-8pm EST) or email sandel-cs@ansell.com

Device

Device Recall Ansell Sandel Weighted Safety Scalpel
  • 모델명 / 제조번호(시리얼번호)
    510 K exempt Device Listing Number D129456 Model Number 2215-N LN 1203 and 1553
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) including states of: AL, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MS, NC, NE, NY, OK, PA, PR, RI, TN, TX and WI; and country of: Canada.
  • 제품 설명
    Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #15 Blade || Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA || Emergo Europe Molenstraat 15 2513 BH The Hague || The Netherlands || Made in China || Packaged in Mexico || Ansell || A manual surgical scalpel blade for making incisions in various general surgical procedures.
  • Manufacturer
    Ansell Sandel Medical Industries LLC

Manufacturer

Ansell Sandel Medical Industries LLC
  • 제조사 주소
    Ansell Sandel Medical Industries LLC, 19736 Dearborn St, Chatsworth CA 91311-6509
  • Source
    USFDA