Events

Recall of Device Recall Comed PICC Insertion Tray

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Integra Pain Management.

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
    47373
  • Event Risk Class
    Class 2
  • Event Number
    Z-1635-2008
  • Event Initiated Date
    2008-03-18
  • Event Date Posted
    2008-08-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-11-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69369
  • 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
    PICC insertion tray - Product Code FMF
  • Reason
    Hep-lock flush vials included in integra's picc insertion trays contain a heparin component that has been recalled by baxter for contaminated heparin.
  • Action
    Integra notified the consignee by letter on 03/18/2008. Instructions were to cease distribution/use of the affected kits and arrange for return to Integra. Also, consignee was instructed to notify all customers who received the kits to cease use and return any affected product for further disposition.

Device

Device Recall Comed PICC Insertion Tray

Manufacturer

Integra Pain Management
  • Manufacturer Address
    Integra Pain Management, 3395 W 1820 S, Salt Lake City UT 84104-4921
  • Manufacturer Parent Company (2017)
    Integra Pain Management
  • Source
    USFDA