Events

Recall of Device Recall Abbott TUR

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Laboratories HPD/ADD.

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
    26348
  • Event Risk Class
    Class 2
  • Event Number
    Z-0934-03
  • Event Initiated Date
    2003-05-13
  • Event Date Posted
    2003-06-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-11-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27545
  • 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
    Set, Administration, Intravascular - Product Code FPA
  • Reason
    The irrigation set was mislabeled with the wrong delivery rate of 8 drops/ml when it actually has a delivery rate of 11 drops/ml.
  • Action
    Recall letter dated 5/12/03 sent to the account on 5/13/03, informing them of the labeling discrepancy and requesting the return of any inventory of the affected lot to Abbott for credit.

Device

Device Recall Abbott TUR
  • Model / Serial
    List number 15252-04-02, lot 940285H
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    New Orleans, LA
  • Product Description
    T-U-R Y-Set Non-Vented Set for Transurethral Resection Procedures For Use with Flexible Irrigation Container System, 84 inch (213 cm) Nominal Length, No. 15252-02; Made in Costa Rica, Abbott Laboratories, North Chicago, IL 60064
  • Manufacturer
    Abbott Laboratories HPD/ADD

Manufacturer

Abbott Laboratories HPD/ADD
  • Manufacturer Address
    Abbott Laboratories HPD/ADD, 100/200 Abbott Park Road, Abbott Park IL 60064
  • Source
    USFDA