Events

Rappel de Device Recall Boston Scientific PT2 Guide Wire

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 Boston Scientific.

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
    36201
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1541-06
  • Date de mise en oeuvre de l'événement
    2006-08-31
  • Date de publication de l'événement
    2006-09-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-06-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48307
  • 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
    Guide Wire - Product Code DQX
  • Cause
    The pt2 j-tip labeled guide wires may be missing the pre-formed j-tip. as a result, guide wires may have a straight tip instead of a pre-formed j-tip.
  • Action
    An Urgent Medical Device Recall letter, dated 08/31/06, was sent to affected customers. The letter describes the issue,states that distribution or use of affected product should cease immediately and replacement product will be issued for all returned devices. A Reply Verification Tracking Form is asked to be completed and returned to Boston Scientific.

Device

Device Recall Boston Scientific PT2 Guide Wire
  • Modèle / numéro de série
    Single Pack - Outer Box UPN H7493893104J0, Inner Pouch UPN H7493893104J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8578445/8498450; 8615997/8579187; 8616986/8428651; 8625889/8542669; 8634387/8592510; 8661236/8615192; 8676306/8623927; 8679477/8614968; 8684638/8614969; 8691987/8614967; 8711404/8615194; 8711707/8640992; 8716167/8615190; 8775301/8721349.     5-Pack - Outer Box UPN H7493893104J2, Inner Pouch UPN H7493893104J0 with the following Outer Box Batch number / Inner Pouch Batch number: 8578446/8498450; 8615998/8579187; 8616987/8428651; 8625890/8542669; 8634388/8592510; 8661241/8615192; 8676307/8623927; 8679478/8614968; 8684639/8614969; 8691990/8614967; 8711405/8615194; 8711708/8640992; 8716168/8615190; 8775302/8721349.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution --- including states of AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NM, NV, OH, OK, PA, SC, TN, TX, WI, WV and Puerto Rico and countries of Austria, Belgium, Bulgaria, Chile, Columbia, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hungary, Italy, Lithuania, Malaysia, Mexico, Norway, Pakistan, Poland, Portugal, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela.
  • Description du dispositif
    Boston Scientific PT2 Moderate Support Guide Wire 300cm J-Tip, Catalog Number 38931-04. Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped ''J'' tip. Made in USA.
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Adresse du fabricant
    Boston Scientific, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Source
    USFDA