Events

Rappel de Device Recall AbbVie PEG Kit 20 FR

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par AbbVie Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    75794
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0786-2017
  • Date de mise en oeuvre de l'événement
    2016-11-22
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151290
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Tubes, gastrointestinal (and accessories) - Product Code KNT
  • Cause
    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
  • Modèle / numéro de série
    AbbVie PEG Kit 20 Fr   Product Code 62912-01-16 with lot numbers: 32025245, 32265215, 32335206, 32335336
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    U.S. consignees located throughout the country and Puerto Rico. Foreign Consignees: Worldwide.
  • Description du dispositif
    AbbVie PEG Kit 20 FR
  • Manufacturer
    AbbVie Inc.

Manufacturer

AbbVie Inc.
  • Adresse du fabricant
    AbbVie Inc., 1 N Waukegan Rd, North Chicago IL 60064-1802
  • Société-mère du fabricant (2017)
    Abbvie Inc.
  • Source
    USFDA