Events

Device Recall WOLFPAK, Medpro, Vipat 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 First Medical Source 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
    60030
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0161-2013
  • 사례 시작날짜
    2011-07-09
  • 사례 출판 날짜
    2012-10-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-09-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104881
  • 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
    Pump, infusion, elastomeric - Product Code MEB
  • 원인
    Please be aware that this is not a new recall. the firm has taken action; but, due to administrative issues this recall is now being reclassified by the agency as a class i. the recall was initiated because first medical source has confirmed that these lots may have a higher flow rate than specified. the use of this product may lead to over-administration of drug solutions to the patients. the pr.
  • 조치
    Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being reclassified by the Agency as a Class I. First Medical Source received an email from Medpro International with the following lnstruction to Customer - Informed customers to remove product from sales/discontinue use, cease distribution, remove the products from inventory and quarantine, inform their customers to retum the unused products to them, and destroy the product. Distributors' customer service will contact the customer to coordinate the return of the goods in question where required. First Medical Source emailed to their customer, Williams Medical Technologies, to informed them of the recall of the Medpro Elastomeric infusion pumps. Customer was instructed to inform them of the date and method of disposal of recalled products.

Device

Device Recall WOLFPAK, Medpro, Vipat
  • 모델명 / 제조번호(시리얼번호)
    AccuFlux, Lot#: 91209.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide distribution in the state of IL
  • 제품 설명
    Medpro Elastomeric Infusion Pump. || AccuFlux, Model # CT-0020-100H. || Product Usage: || The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and administered accordance with the drug manufacturers package insert. The devices deliver controlled amounts of medication directly to the intraoperative site for pain management and or antibiotic administration. The devices infuse the medication at an hourly flow rate. Medications are infused intraoperatively and postoperatively through intramuscular or subcutaneous routes. The devices are also intended for controlled delivery of local anesthetics in close proximity to nerves for post operative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous. It is for continuous infusion of medications for general infusion use, including antibiotic delivery and chemotherapy.
  • Manufacturer
    First Medical Source LLC

Manufacturer

First Medical Source LLC
  • 제조사 주소
    First Medical Source LLC, 28581 Springfield Dr, Laguna Beach CA 92677-1424
  • 제조사 모회사 (2017)
    First Medical Source Llc
  • Source
    USFDA