Events

Rappel de Arrow

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
    72463
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0207-2016
  • Date de mise en oeuvre de l'événement
    2015-10-16
  • Date de publication de l'événement
    2015-11-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-11-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141136
  • 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
    Possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. although the issue does not pose a significant risk to the patient, it may cause a delay of treatment when placing the catheter.
  • Action
    Arrow International sent an Urgent Medical Device Recall Notification letter dated October 16, 2015, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignees. Consignees were instructed to immediately discontinue use and quarantine any effected products. Consignees were instructed to return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507 Attn: Customer Service or email it to recalls@teleflex.com. A customer service representative will contact consignees with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Arrow International. For consignees with no affected product, should also complete the enclosed Recall Acknowledgement Form. For questions customers should call 1-866-246-6990.

Device

Arrow
  • Modèle / numéro de série
    Product Codes ASK-45552-RWJ3 CDC-35541-HPK1A EU-00750-45 PL-00750 AU-00420-MAJO CDC-35541-VPS EU-02041-ML PL-00755 CDC-34041-HPK1A CDC-35552-HPK1A EU-24041-HPMSB PR-35552-HPHNM CDC-34041-VPS CDC-35552-VPS EU-24052-HPMSB PR-45563-HPHNM CDC-34052-HPK1A CDC-41563-JX1A EU-25041-HPMSB UK-00420-MID CDC-34052-VPS CDC-44041-HPK1A EU-25052-HPMSB UK-00420-RCHT CDC-35041-HPK1A CDC-44052-HPK1A EU-25063-HPMSB UK-00420-THT CDC-35041-VPS CDC-44063-HPK1A EU-25541-HPMSB UK-04041-RDEH CDC-35052-HPK1A CDC-45063-HPK1A EU-25552-HPMSB UK-05041-MSB CDC-35052-VPS CDC-45563-HPK1A IB-01652 UK-05041-RDEH CDC-35063-HPK1A EU-00740-45 PL-00740 UK-05052-RCHT
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    World Wide Distribution - US including AR, AL, TX, MA, CA, IA, MO, NY, AL, VA, RI, IN, TN, FL, KY, NH, SC, MD, WA, OK, IL, ME, OR, OH, PA, MI, KS, LA, TN, WV, NE, NJ, NV, GA, SD, CT, MS, CO, and Internationally to Canada and Belgium.
  • Description du dispositif
    ARROW PICC Kit featuring Chlorag+ard Technology || Midline Catheterization Kit || ARROW Advantage5 Pressure Injectable PICC Kit || Arrow¿ Pressure Injectable Arrow¿ PICC powered by Arrow¿ VPS¿ Stylet || ARROW Pressure Injectable JACC with Chlorag+ard Technology || For short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. Permits venous access to the peripheral circulation. Offers an alternative method of intravenous access for select adult and pediatric patients. The ARROW GlideThru Peel-Away Sheath/Dilator is used for the percutaneous introduction of diagnostic or therapeutic devices into the vasculature.
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • Adresse du fabricant
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    USFDA