Device Recall HEMOCATH, SLX, PROPICC, VASCUPICC

  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: MBWK970, MBWH890, MBWJ180, MBWJ460, MBWH910, MBWH940
  • 의료기기 분류등급
  • 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
  • 1 Event

제조사

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