Events

Rappel de Celerity PICC Tip Confirmation System

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 Angiodynamics Inc. (Navilyst Medical 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
    75226
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1137-2017
  • Date de mise en oeuvre de l'événement
    2016-09-07
  • Date de publication de l'événement
    2017-02-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-04-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149720
  • 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
    Tracheotome - Product Code LJW
  • Cause
    The celerity ecg cable accessory pack has the potential to contain an ecg clip cable that was not properly manufactured. the affected product is not soldered per specification, and may result in the device not properly conducting the ecg signal.
  • Action
    On 9/7/2016, AngioDynamics, Inc. sent URGENT VOLUNTARY MEDICAL DEVICE RECALL Notifications (dated 9/7/2016) to 47 consignees via Federal Express. Consignees were instructed to segregate and return all affected devices to AngioDynamics and complete and return the Reply Verification Tracking Form, provided in the recall notification. Please call AngioDynamics Customer Service at 1-800-772-6446 Monday - Friday between 8:00 am and 7:00 Pm EST to obtain a replacement or credit for returned product.

Device

Celerity PICC Tip Confirmation System
  • Modèle / numéro de série
    AngioDynamics UPN H787471431 Batch/Lot Numbers: 5015180, MBVR240D, MBVT150R, MBVT210D, MBVT220D, MBVT240D, MBVT250D, MBVT680D, MBVT700D, MBVX090D; medCOMP UPN MRLCA000, Batch/Lot Number MBVT240.
  • Classification du dispositif
    Ear, Nose, and Throat Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    AZ, CA, FL, GA, IL, IN, KS, MD, MO, MT, NC, NJ, NV, OH, OR, PA, TN, TX, WI
  • Description du dispositif
    Celerity ECG Cable Accessory Pack, STERILE, Rx ONLY - distributed under the following labels: (a) angiodynamics UPN/Product No. H787471431, REF/Catalog No. 47-143 -- Legal Manufacturer: AngioDynamics, Inc. 10 Glens Falls Technical Park, Glens Falls, NY 12801; and (b) medCOMP UPN/Product No. MRLCA000, REF/Catalog No. MRLCA000 -- medCOMP, 1499 Delp Drive, Harleysville, PA 19438 --- Description: The Celerity ECG Cable Accessory Pack is comprised of two sterile, single use components: a cable cover and an ECG clip cable (alligator clip). The cable cover is used to sleeve the remote control cable component of the Celerity System so that the user can remotely control the monitor within the sterile field. The stereo jack end of the remote control cable pierces the sterile cable cover and interfaces with the stereo jack connector end of the ECG clip cable. The alligator clip side of the ECG clip cable is clamped to the stylet or guidewire to provide the intravascular cavity ECG reading.
  • Manufacturer
    Angiodynamics Inc. (Navilyst Medical Inc.)

Manufacturer

Angiodynamics Inc. (Navilyst Medical Inc.)
  • Adresse du fabricant
    Angiodynamics Inc. (Navilyst Medical Inc.), 10 Glens Falls Tech Park, Glens Falls NY 12801-3864
  • Société-mère du fabricant (2017)
    AngioDynamics Inc
  • Source
    USFDA