Events

Rappel de Device Recall Arrow International StimuCath(R) Continuous Nerve Block Kit, ASK19608SFH

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 Arrow International 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
    60314
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0309-2012
  • Date de mise en oeuvre de l'événement
    2011-06-20
  • Date de publication de l'événement
    2011-11-30
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-10-01
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105014
  • 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
    Anesthesia conduction kit - Product Code CAZ
  • Cause
    Some of the outer trays used in the packaging of the ask-19608-sfh continuous nerve block kits, lot # mf0127039 were found to have an insufficient seal. therefore, the packaging may have been compromised, and sterility of the product cannot be guaranteed.
  • Action
    The firm, Arrow International, sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 20, 2011, to its customer. The letter included a stock response form to be completed and returned to the firm. The letter also described the product, problem and action to be taken. The customer was instructed to check their stock for the products included in the scope of the recall; cease use and distribution; quarantine all affected product immediately; complete and return the enclosed Recall Acknowledgement & Stock Status Form to their sales representative, and return any affected product freight collect to: Arrow International, Inc., 312 Commerce Place, Asheboro, NC 27203, attn: Asheboro Quality Assurance Manager. Arrow International can provide replacement with a similar product or credit their account. If you have questions or concerns, please call this toll free number 800-233-3187.

Device

Device Recall Arrow International StimuCath(R) Continuous Nerve Block Kit, ASK19608SFH
  • Modèle / numéro de série
    Lot number MF0127039
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: CT
  • Description du dispositif
    Arrow International StimuCath(R) Continuous Nerve Block Kit, ASK-19608-SFH, Lot # MF0127039 || Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia of analgesia techniques for periods not exceeding 72 hours
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • Adresse du fabricant
    Arrow International Inc, 2400 Bernville Road, Reading PA 19605
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    USFDA