Events

Rappel de Device Recall WOLFPAK, Medpro, Vipat

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 First Medical Source 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
    60030
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0161-2013
  • Date de mise en oeuvre de l'événement
    2011-07-09
  • Date de publication de l'événement
    2012-10-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-09-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104881
  • 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
    Pump, infusion, elastomeric - Product Code MEB
  • Cause
    Please be aware that this is not a new recall. the firm has taken action; but, due to administrative issues this recall is now being reclassified by the agency as a class i. the recall was initiated because first medical source has confirmed that these lots may have a higher flow rate than specified. the use of this product may lead to over-administration of drug solutions to the patients. the pr.
  • Action
    Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues this recall is now being reclassified by the Agency as a Class I. First Medical Source received an email from Medpro International with the following lnstruction to Customer - Informed customers to remove product from sales/discontinue use, cease distribution, remove the products from inventory and quarantine, inform their customers to retum the unused products to them, and destroy the product. Distributors' customer service will contact the customer to coordinate the return of the goods in question where required. First Medical Source emailed to their customer, Williams Medical Technologies, to informed them of the recall of the Medpro Elastomeric infusion pumps. Customer was instructed to inform them of the date and method of disposal of recalled products.

Device

Device Recall WOLFPAK, Medpro, Vipat
  • Modèle / numéro de série
    AccuFlux, Lot#: 91209.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide distribution in the state of IL
  • Description du dispositif
    Medpro Elastomeric Infusion Pump. || AccuFlux, Model # CT-0020-100H. || Product Usage: || The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and administered accordance with the drug manufacturers package insert. The devices deliver controlled amounts of medication directly to the intraoperative site for pain management and or antibiotic administration. The devices infuse the medication at an hourly flow rate. Medications are infused intraoperatively and postoperatively through intramuscular or subcutaneous routes. The devices are also intended for controlled delivery of local anesthetics in close proximity to nerves for post operative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous. It is for continuous infusion of medications for general infusion use, including antibiotic delivery and chemotherapy.
  • Manufacturer
    First Medical Source LLC

Manufacturer

First Medical Source LLC
  • Adresse du fabricant
    First Medical Source LLC, 28581 Springfield Dr, Laguna Beach CA 92677-1424
  • Société-mère du fabricant (2017)
    First Medical Source Llc
  • Source
    USFDA