Device Recall Various catheters marketed by Medcomp and AngioDynamics

  • 모델명 / 제조번호(시리얼번호)
    Medcomp products:Catalog Code/ Lot Number/Expiration Date: DFXL148MTE/ MGMC610/10/31/2019; HFS 32/ MGMB440/ 07/14/2017;  HFS24E./MGLY830/07/31/2017; MC061402/MGMD190/07/15/2017;  MC3L-8S/MGMD920/10/16/2019; MR17035211/MGMD680/10/31/2017;  TRAY #593-3/MGMB460/07/15/2017; RMS23602/MBWM930/07/31/2017;  ASPC2816-3/MBWM900/07/31/2017; Tray #55216-3/MBWL780/07/31/2017; ASPC2816-3PC/MBWX290/07/31/2017; 10301207/MGMD930/07/31/2017; 10800701/ MGLY730/ 07/31/2017; 10800702/ MGMD210/ 07/31/2017; 10800703/MGLY740/07/31/2017   AngioDynamics products- model numbers/lot numbers/ expiration dates:  10301207/MGMD930/07/31/2017; 10800701/MGLY730/07/31/2017; 10800702/MGMD210/07/31/2017; 10800703/MGLY740/07/31/2017
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution.
  • 제품 설명
    Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III; || AngioDynamics product- Dura-Flow Catheter, Schon XL Catheter; The affected product are insertion kits used to implant the devices packaged-long and short term hemodialysis catheters and infusion catheters.
  • Manufacturer
  • 1 Event

제조사

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