Events

Rappel de Covidien

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 Covidien LLC.

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
    65978
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2186-2013
  • Date de mise en oeuvre de l'événement
    2013-08-16
  • Date de publication de l'événement
    2013-09-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-10-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121131
  • 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
    Saline, vascular access flush - Product Code NGT
  • Cause
    Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin.
  • Action
    Covidien sent an Urgent Medical Device Recall letter dated August 16, 2013 via Federal Express to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter requested that customers immediately quarantine and discontinue use of the affected products, return any affected product by following the instructions provided in the letter, and complete and return the Recalled Product Return Form to Covidien. The letter states that if the affected products have been distributed, assure that all customers are notified and affected product is removed from the distribution channel as well as from customer stock. Questions or concerns, please do not hesitate to contact your Covidien representative or Covidien Customer Service, Monday through Friday, 8am- 6:30pm ET, at (800) 962-9888, option 1, and then option 2. Firm issued Press on 8/19/13

Device

Covidien
  • Modèle / numéro de série
    Lot Numbers:  13A0084N 13D0824N
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide and the country of Bermuda
  • Description du dispositif
    Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill || Product ID: 8881590125 || Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible intravenous administration sets and indwelling intravenous access devices
  • Manufacturer
    Covidien LLC

Manufacturer

Covidien LLC
  • Adresse du fabricant
    Covidien LLC, 15 Hampshire Street, Mansfield MA 02048-1113
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA