Rappel de Device Recall AGB Pressure Injectable Multi

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
  • ID de l'événement
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
  • Date de mise en oeuvre de l'événement
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • 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,short-term less than 30 days - Product Code FOZ
  • Cause
    Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and unique device identification (udi) information.
  • Action
    On November 29, 2017 an Urgent Medical Device Correction notice was issued to customers stating the following: Our records indicate that you have received products that are subject to this action. We are now notifying our distributors to take the following actions: 1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed above. 2. Inspect affected products within your control to identify whether they have the sticker with the lot number, expiration date, and UDI information. Products missing this sticker should be returned to Arrow International so they are not distributed to health care providers in error. Products which are properly labeled should not be returned. 3. Using the provided Customer Letter and Acknowledgement Form templates, communicate this correction to any of your customers who have received products included within the scope of the correction. Customers should return mislabeled products. Products that are properly labeled should not be returned. 4. If any of your customers have mislabeled products to return, have them return the affected products to you, together with a completed Acknowledgement Form, for consolidation and return to Arrow International. In the event that an alternative approach is needed, contact Customer Service for more information at 1-866-246-6990. 5. To return products to Arrow International, complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Arrow International. 6. If you and your customers have no affected stock or if the products in your stock are properly labeled, please complete the enclosed Acknowledgment Form and fax it to 1-855-419


  • Modèle / numéro de série
    CA-42703-P1A 13F16M0047 13F17B0152 13F16K0302 13F17F0226 13F17H0407 13F17A0157 13F17B0117 13F17C0250 13F17F0259 13F17H0100  13F17C0057 13F17F0298 13F17H0068
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    US in the states of OH, FL, SC, TX, KY, NJ, MI
  • Description du dispositif
    AGB+ Pressure Injectable Multi- Lumen CVC Kit || Product Usage: || The Arrow¿ CVC is indicated to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: multiple infusions of fluids, medications, or chemotherapy infusion of fluids that are hypertonic, hyperosmolar, or have divergent pH values frequent blood sampling or blood/blood component infusions infusion of incompatible medications central venous pressure monitoring lack of usable peripheral IV sites replacement of multiple peripheral sites for IV access injection of contrast media When used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with pressure injectable CVC may not exceed 400 PSI.
  • Manufacturer


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