Events

Recall of Device Recall 9F Plastic Dual Port

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medical Components, Inc dba MedComp.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70457
  • Event Risk Class
    Class 2
  • Event Number
    Z-1527-2015
  • Event Initiated Date
    2015-01-28
  • Event Date Posted
    2015-04-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=133828
  • Notes / Alerts
    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.
  • Extra notes in the data
    Port and catheter, implanted, subcutaneous, intravascular - Product Code LJT
  • Reason
    The dual port with catheters was not covered under fda clearance.
  • Action
    Sales reps were notified by email on/about January 28, 2015, and instructed to notify their medical facilities and provide the recall letter. This will be accomplished by either email, telephone, or visit. Every consignee will be requested to complete and return Page 2 of the recall letter verifying receipt of the recall and disposition of the product they received.

Device

Device Recall 9F Plastic Dual Port
  • Model / Serial
    Model No. MR592090A, MR592090P; with Lot Nos.:  MAKT120 EXP. DATE 04/28/2012, MAXH410 EXP. DATE 06/28/2014, MAXF610 EXP. DATE 10/28/2014, MBFC140 EXP. DATE 05/28/2016, MBGH020 EXP. DATE 08/28/2016, MBHS100 EXP. DATE 11/28/2016, MAKT130 EXP. DATE 04/28/2012, MBAQ860 EXP. DATE 07/28/2015, MBHP980 EXP. DATE 11/28/2016, MBKJ110 EXP. DATE 03/28/2017
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution. US nationwide, Canada, Brazil, and United Arab Emirates.
  • Product Description
    9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide repeated vascular access and are applicable for delivery of: medications, intravenous fluids, blood products, parenteral nutrition, and for venous blood sampling.
  • Manufacturer
    Medical Components, Inc dba MedComp

Manufacturer

Medical Components, Inc dba MedComp
  • Manufacturer Address
    Medical Components, Inc dba MedComp, 1499 Delp Dr, Harleysville PA 19438
  • Manufacturer Parent Company (2017)
    Medical Components Inc.
  • Source
    USFDA