Events

Rappel de Southmedic/Personna Safety Scalpel

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 Southmedic, 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
    56963
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0988-2011
  • Date de mise en oeuvre de l'événement
    2010-09-03
  • Date de publication de l'événement
    2011-01-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-05-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95057
  • 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
    One-Piece Scalpel - Product Code GDX
  • Cause
    Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile.
  • Action
    On 9/3/2010, the firm notified consignees about the recall by facsimile letter. The letter instructed consignees to return scalpels for credit or replacement. The firm enlarged the scope of the recall on 11/15/2010. An additional 927 cases were recalled. This includes 11 additional lots. The firm sent out URGENT MEDICAL DEVICE RECALL letters dated 11/15/2010 to its direct accounts. The letter identified that affected product and the reason for the recall. The consignees were instructed to check their inventory, complete and return the attached Voluntary Recall Notification Confirmation Form, return the affected product to the manufacturer. Product return question should be directed towards Marc Pauze at 800-463-7146 ext 299 and regulatory questions should be directed towards Tish Anger at 800-463-7146 ext 342.

Device

Southmedic/Personna Safety Scalpel
  • Modèle / numéro de série
    Lot numbers: 070610, 82010, 82610, and 91710.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of TX, MO, NJ, LA, IL, NY, KY, PA, VA, WA, CA, MA, MD, IN, NV, TN, NC, AZ, IA, WI, UT, NE, GA, FL, MN, ME, OH, SD, and KS and countries of Australia and Canada.
  • Description du dispositif
    Southmedic/Personna Safety Scalpel with Personna Plus Blades, Reorder No. 73-0610, Size #10, General Surgical Use, Sterile, unless package is damaged or opened., Southmedic Inc., 50 Alliance Blvd., Barrie, ON., Canada L4M 5K3 www.southmedic.com, Made in Canada.
  • Manufacturer
    Southmedic, Inc.

Manufacturer

Southmedic, Inc.
  • Adresse du fabricant
    Southmedic, Inc., 50 Alliance Blvd., Barrie Canada Ontario
  • Société-mère du fabricant (2017)
    Southmedic Incorporated
  • Source
    USFDA