Events

Recall of Device Recall Jejunal Feeding Set

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

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
    52758
  • Event Risk Class
    Class 2
  • Event Number
    Z-1910-2009
  • Event Initiated Date
    2009-07-24
  • Event Date Posted
    2009-09-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-04-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83888
  • 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
    Gastrointestinal Tubes and Accessories - Product Code KNT
  • Reason
    The english only version of the patient care manuals that accompany the device were shipped to a medical facility in italy.
  • Action
    The consignee was notified by an Urgent: Field Safety Notice, dated 07/24/2009. The distributor (Cook Ireland) was instructed to contact the Italian Company Representative. The appropriate Patient Care Manual with the Italian translation was provided to the medical facility with the assistance of the Area Representative. The Area Representative instructed the medical facility staff to provide the translated Patient Care Manual to the caregiver(s) of the patient that received the Jejunal Feeding Sets. The distributor is already aware of the situation. The lower portion of the letter was to be filled out and sent to Cook Endoscopy.

Device

Device Recall Jejunal Feeding Set
  • Model / Serial
    Lot number W2676476
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    International Only Distribution -- Country of Italy.
  • Product Description
    Jejunal Feeding Set, Product Order number FLOWJ-9-20. || This device is used for percutaneous endoscopic placement to provide enteral nutrition to patients requiring nutritional support.
  • Manufacturer
    Cook Endoscopy

Manufacturer

Cook Endoscopy
  • Manufacturer Address
    Cook Endoscopy, 5951 Grassy Creek Blvd, Winston Salem NC 27105-1206
  • Source
    USFDA