Events

Recall of Jet Medical 4F x 60cm Single Lumen Polyurethane PICC Nursing Tray

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
    33789
  • Event Risk Class
    Class 3
  • Event Number
    Z-0103-06
  • Event Initiated Date
    2005-09-15
  • Event Date Posted
    2005-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42443
  • 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
    Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
  • Reason
    The product is labelled as containing a 4f catheter when the trays/kits actually contain a 5f catheter. the catheters will not fit into the sheath-dilator that was included in the tray. mislabeled as 4f.
  • Action
    On 9/15/05, the recalling firm telephoned the two distributors to inform them of the problem and the need to return the product.

Device

Jet Medical 4F x 60cm Single Lumen Polyurethane PICC Nursing Tray

Manufacturer

Medical Components, Inc dba MedComp
  • Manufacturer Address
    Medical Components, Inc dba MedComp, 1499 Delp Dr, Harleysville PA 19438-2936
  • Manufacturer Parent Company (2017)
    Medical Components Inc.
  • Source
    USFDA