Events

Rappel de Device Recall Peripherally Inserted Central Catheters (PICC)

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
    75322
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0708-2017
  • Date de mise en oeuvre de l'événement
    2016-08-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-06-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150100
  • 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
    Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
  • Cause
    Medline industries, inc. supplies navilyst with sterile package gloves included in the tandem packing of the maximal barrier nursing kits. medline has determined that specific lots of the gloves supplied to navilyst contain an incorrect expiration date. navilyst has confirmed that medlines affected sterile gloves (medline part number msg1075/msg3075) have been included in a limited number of kits.
  • Action
    Navilyst sent an Urgent Voluntary Medical Device Recall notices, reply forms and a copy of Medline's Recall Notice to the their customers. The letter identified the product, the problem, and the action to be taken by the customer. Navilyst Medical, Inc. (an AngioDynamics Company), the manufacturer of the Xcela" PICC w/PASV, the BioFlo PICC w/ Endexo, and the BioFlo PICC w/ Endexo and PASV is conducting a medical device recall based on information received from Medline. Medline has determined that the sterile gloves listed in their Recall Notification dated August 3, 2016 may contain an incorrect expiration date. Actions to be taken: - Customers should immediately remove the affected product from inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). - Segregate this product in a secure location for return to Navilyst Medical. - Immediately forward a copy of this recall notification to all sites to which customers may have further distributed affected product. Customers should also promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return) via email to recall@angiodynamics.com. Customers with questions can call 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday  Friday: Eastern Standard Time). For questions regarding this recall 518-792-4112.

Device

Device Recall Peripherally Inserted Central Catheters (PICC)
  • Modèle / numéro de série
    Batch/Lot: 505722, 5056512
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including AZ, CA, FL, GA, HI, IL< IN< KS, LA, MI, MN, MO, ND, NM, OH, OR, PA, TN, TX, WA & the District of Columbia.
  • Description du dispositif
    Xcela Power Injectable PICC Maximal Barrier Nursing Kit || The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media
  • 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