Events

Recall of Device Recall AbbVie PEG Kit 20 FR

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

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
    75794
  • Event Risk Class
    Class 2
  • Event Number
    Z-0786-2017
  • Event Initiated Date
    2016-11-22
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151290
  • 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
    Tubes, gastrointestinal (and accessories) - Product Code KNT
  • Reason
    Abbvie is issuing an urgent field correction notification due to an increased number of reports of disconnections of the abbvie 20fr peg tube from the y-connectors.
  • Action
    The firm sent an URGENT: MEDICAL DEVICE FIELD CORRECTION NOTIFICATION AbbVie PEG Kit 20 FR to affected customers describing the reason for the notification. The letter asks affected customers to forward this letter to all Movement Disorder Specialists and physicians (e.g. GIs, IRs, and surgeons) that place PEG- J Tubes within your facility. The letter describes actions to be taken for patients still using the AbbVie PEG 20FR Tube. The letter requests user facilities to continue to monitor the performance of the Tube. The firm states that there is no need to replace the AbbVie PEG 20FR Tube if it is functioning as expected and maintaining a viable connection with the Y-Connector. The letter provides the following instructions when establishing a connection between Abbvie PEG 20FR Tube with the 20FR Y-connector, always refer to AbbVie J Intestinal Tube 9 FR to PEG 15 and 20 FR Instructions for Use for 62918-001. The letter notes the following: 1. Ensure that the set-up process clearly follows the sequence of events as described in the instructions for use and the following clarifications. 2. Ensure that the AbbVie PEG 20FR tube is connected to the corresponding 20 Y- connector (see photograph below which shows the difference between the 15FR and 20FR connection diameter). 3. DO NOT USE ALCOHOL CONTAINING PRODUCTS with the AbbVie PEG 20 FR tube as this may result in damage to the tube. 4. Ensure that the Tube Clamp and Tube Clip on Fixation Plate are both closed. 5. Cut off the proximal cone and Fixation Loop of the AbbVie PEG Tube (15FR or 20FR). Note: Ensure that the cut is perpendicular (90 degree angle) to the tube and not on a diagonal as this ensures proper seating of the tube when engaged into the pin of the Y-connector fitting. 6. Slide the colored Fixation Screw (including the outer ring) over the Abbvie PEG Tube: a. For 15 FR, use the Blue/White screw b. For 20 FR, use the Violet/White screw 7. Grasp near the

Device

Device Recall AbbVie PEG Kit 20 FR
  • Model / Serial
    AbbVie PEG Kit 20 Fr   Product Code 62912-01-16 with lot numbers: 32025245, 32265215, 32335206, 32335336
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    U.S. consignees located throughout the country and Puerto Rico. Foreign Consignees: Worldwide.
  • Product Description
    AbbVie PEG Kit 20 FR
  • Manufacturer
    AbbVie Inc.

Manufacturer

AbbVie Inc.
  • Manufacturer Address
    AbbVie Inc., 1 N Waukegan Rd, North Chicago IL 60064-1802
  • Manufacturer Parent Company (2017)
    Abbvie Inc.
  • Source
    USFDA