Events

Rappel de Device Recall VASCUGUARD Pheripheral Vascular Patch

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 Synovis Surgical Innovations, 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
    71191
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1637-2015
  • Date de mise en oeuvre de l'événement
    2015-05-02
  • Date de publication de l'événement
    2015-05-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-02-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136433
  • 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
    Patch, pledget and intracardiac, petp, ptfe, polypropylene - Product Code DXZ
  • Cause
    Baxter healthcare is recalling specific product codes of vascu-guard peripheral vascular patch due to complaints received for difficulty in distinguishing the smooth from rough surface.
  • Action
    The firm, Baxter, sent an "Urgent Product Recall" letter dated 5/2/2015 via USPS overnight delivery to its customers. The letter identified the affected product, problem and actions to be taken. The customers were instructed to immediately discontinue use and segregate the affected product, locate and remove all affected product from your facility and to return it to Baxter. Customers are to contact Baxter Healthcare Center, 888-229-0001, for Service to arrange for return and credit. In addition, the customers were to complete and return the Customer Reply Form by faxing to 224-270-5457 or emailing to fca@baxter.com. If you have any questions, contact Director, Quality at 651-796-7543 or email: heidi_drafall@baxter.com.

Device

Device Recall VASCUGUARD Pheripheral Vascular Patch
  • Modèle / numéro de série
    all lot numbers
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm, product code 1504030, and 2x9cm, product code 1504032. VASCU-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile. VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.
  • Manufacturer
    Synovis Surgical Innovations, Inc.

Manufacturer

Synovis Surgical Innovations, Inc.
  • Adresse du fabricant
    Synovis Surgical Innovations, Inc., 2575 University Ave W, Saint Paul MN 55114-1073
  • Société-mère du fabricant (2017)
    Baxter International
  • Source
    USFDA