Events

Rappel de Device Recall Integra Long Epidural Steroid Injection Needle (Tuohy Needle)

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 Integra LifeSciences Corp. d.b.a. Integra Pain Management.

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
    71147
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2056-2015
  • Date de mise en oeuvre de l'événement
    2015-05-01
  • Date de publication de l'événement
    2015-07-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-12-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136261
  • 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
    Needle, conduction, anesthetic (w/wo introducer) - Product Code BSP
  • Cause
    Integra lifesciences corp. d.B.A. integra pain management announces voluntary recall of tuohy needles (20 gauge, 5 inch) due to incorrect packaging (labeled as 18 gauge, 3. 5 inch).
  • Action
    Integra sent an Urgent Voluntary Medical Device Recall letter dated May 1, 2015, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Integra is asking customers to do the following: 1. Review your inventory and determine if you have Tuohy Needle, 20 Gauge X 5 inches (Cat. No. PITRW2050) with an affected Lot Number that is listed on page 2. If so, stop using them immediately and remove them from service. 2. Complete the attached form. If you do not have affected product, check the box:  I do not have any product(s) with a Lot Number from the list below. 3. If you do have affected product, check the box:  I do have product(s) with a Lot Number from the list below. 4. Complete the other information on the form and return it by email or fax as indicated on the form. Keep a copy of the form for your records. When your form is received, Customer Service will contact you and provide an RMA number and directions to return and replace the affected products. Should you have any questions regarding these instructions, please contact Customer Service at 1-800-241-2210. For questions regarding this recall call 609-936-6822.

Device

Device Recall Integra Long Epidural Steroid Injection Needle (Tuohy Needle)
  • Modèle / numéro de série
    W1404274, W1407165, W1409136, W1410082, W1412056, W1501065, W1501181
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX). Integra¿ Long Epidural Steroid Injection Needle (Catalogue #PITRW2050). Peel Pouch. The Integra¿ Long Epidural Steroid Injection Needle is packaged in a labeled and sterilized sealed tyvek / plastic pouch. The sterilized pouches are subsequently packaged in a case of 10 that is labeled, sealed and distributed to customers. || Pain management procedure trays contain Tuohy Epidural Injection Needles to administer steroid medication in the epidural space. The needles are also available as an individually packaged single use, sterile device, as was the case with the affected lot in question.
  • Manufacturer
    Integra LifeSciences Corp. d.b.a. Integra Pain Management

Manufacturer

Integra LifeSciences Corp. d.b.a. Integra Pain Management
  • Adresse du fabricant
    Integra LifeSciences Corp. d.b.a. Integra Pain Management, 3498 West 2400 South #1050, Salt Lake City UT 84119
  • Société-mère du fabricant (2017)
    Integra LifeSciences Holdings Corporation
  • Source
    USFDA