Events

Device Recall HEMOCATH, SLX, PROPICC, VASCUPICC 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medical Components, Inc dba MedComp 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
    70351
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1083-2015
  • 사례 시작날짜
    2015-01-21
  • 사례 출판 날짜
    2015-02-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-08-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133239
  • 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
    Catheter, subclavian - Product Code LFJ
  • 원인
    Drug products contained within the kits may have been rendered ineffective by a duplicate sterilization process. the kits include one or more of the following drugs: 5ml ampule of lidocaine, 3ml chloraprep one-step, 10ml pre-filled saline syringe, hygea saline wipes, and 3ml tinted chloraprep. no injuries or illnesses were reported.
  • 조치
    Medcomp sent a Product Alert/Recall letter dated January 21, 2015 to customers via email. The letter identified the affected product, problem and actions to be taken. Medcomp requested the return of all affected product. Customers were instructed to contact their customer service representative for instructions for returning the product.

Device

Device Recall HEMOCATH, SLX, PROPICC, VASCUPICC
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: MBWK970, MBWH890, MBWJ180, MBWJ460, MBWH910, MBWH940
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM LT HEMO-CATH), MC061422 (14FX15CM SLX DBL LMN ST CATH), || MRCTP41017 (4F X 55CM SINGLE CT PICC), MRCTP52007 (5F DUAL PRO-PICC NURSING TRAY), MRCTP52010 (5F DUAL PRO-PICC MAX BARR TRAY), || MR81013106MB (3FX60CM SGL TAPRLS VASCU-PICC). || Intended uses: To attain long-term vascular access for hemodialysis and apheresis. || The Medcomp SLX Silicone Double Lumen Catheter is designed for acute hemodialysis and apheresis. The Pro-PICC¿ CT catheter is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media, and allows for central venous pressure monitoring. The Peripherally Inserted Central Vein Access Catheters are designed for Long or Short- Term peripheral access to the central venous system for intravenous therapy and blood sampling, and allows for central venous pressure monitoring.
  • Manufacturer
    Medical Components, Inc dba MedComp

Manufacturer

Medical Components, Inc dba MedComp
  • 제조사 주소
    Medical Components, Inc dba MedComp, 1499 Delp Dr, Harleysville PA 19438
  • 제조사 모회사 (2017)
    Medical Components Inc.
  • Source
    USFDA