Events

Recall of Spirotome

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cook Medical Incorporated.

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
    69417
  • Event Risk Class
    Class 2
  • Event Number
    Z-0124-2015
  • Event Date Posted
    2014-10-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130489
  • 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
    Instrument, biopsy - Product Code KNW
  • Reason
    Medinvents, the manufacturer of the spirotome" soft-tissue biopsy needle set distributed by cook medical, has initiated a voluntary recall of these products. the recall has been initiated due to customer complaints that the protective caps were dislodged in the pouch. further investigation disclosed potential dislodging of protective caps on the needle tips on other distributed products.
  • Action
    On 9/26/2014, URGENT: MEDICAL DEVICE RECALL notifications were sent to the affected distributors and institutions Risk Managers/Recall Administration with instructions for returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call Customer Relations at 1-800-457-4500 or 1-812-339-2235.

Device

Spirotome
  • Model / Serial
    Model Numbers: SS-08-06; SS-08-10; SS-08-15; SS-10-06; SS-10-10;  SS-10-15; SS-14-06; SS-14-10; SS-14-15.   Lot numbers: P030214C; P020413A; P190813B; P020413B; P030214A; P020413F; P300913A; P020413D; P190813D; P030214B; P020413E; P190813F; P300913B; P020413C; P190813E.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of Arizona, California, Colorado, Hawaii, Iowa, Illinois, Massachusetts, Maryland, Michigan, Missouri, New Mexico, Pennsylvania, Texas, Virginia, Vermont, and Wisconsin, and the countries of AT; BE; CH; CY; CZ; DE; DK; ES; FI; FR; GB; HU; IC; IE; IS; IT; LB; LT; LU; NL; NO; PT; QA; SE; TR; and ZA.
  • Product Description
    Spirotome" Soft-Tissue Biopsy Needle Set. || The Spirotome Biopsy Needle Set includes a two-part introducer needle that consists of a cutting cannula and a trocar stylet, a helical-tip biopsy needle that has been sized to fit through the lumen of the cutting cannula. The Spirotome Biopsy Needle Set is intended for percutaneous acquisition of soft tissue specimens for laboratory analysis.
  • Manufacturer
    Cook Medical Incorporated

Manufacturer

Cook Medical Incorporated
  • Manufacturer Address
    Cook Medical Incorporated, 400 N Daniels Way, Bloomington IN 47404-9155
  • Manufacturer Parent Company (2017)
    Cook Group Incorporated
  • Source
    USFDA