Events

Rappel de Device Recall bipolar cord

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 Olsen Medical.

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
    80080
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1942-2018
  • Date de mise en oeuvre de l'événement
    2018-05-11
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164428
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Cause
    Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised.
  • Action
    Symmetry initiated their recall via Urgent Medical Device Recall notices on 05/11/2018 sending faxes to accounts, as applicable; and, will also send the Notice via US certified mail, with return receipt requested, and will also send the Notice via e-mail to those customers for which it has a valid e-mail address (as applicable). All customers were asked to quarantine any products that reflect a breach of the seal area or any products that they do not wish to inspect immediately and promptly call (800) 251-3000 for a return material authorization (RMA) number to support the return of the impacted Products. All customers outside of the United States (OUS) will be provided with the Notice via postal mail and through Symmetrys Distributors in each country and requested to quarantine immediately and promptly call Symmetry's Distributors to support the return of any products that have a breach of the seal area or which the customer does not wish to inspect. Appropriate notifications will be sent to Health Authorities in Canada, European Union, and other countries that require notification of this recall.

Device

Device Recall bipolar cord
  • Modèle / numéro de série
    all codes
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution
  • Description du dispositif
    Symmetry Olsen bipolar cord: || (a) Bipolar Cord, Twin Pin Connector to Shrouded Instrument Connector, 12' (3.6m), REF 87500, QTY 50 || (b) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102, QTY 10 || (c) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1102SPC, QTY 10 || (d) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF 40-1103, QTY 50 || (e) Bipolar Cord, Twin Pin Connector, Angled 45o, 12' (3.6m), REF 40-1104, QTY 10 || (f) Bipolar Cord, 28 mm Fixed Pin Connector, REF 40-1105-28, QTY 10 || (g) Bipolar Cord, 39 mm Fixed Pin Connector, REF 40-1105-39, QTY 10 || (h) Bipolar Cord, 28 mm Fixed Pin Connector, Angled 45o, REF 40-1106-28, QTY 10 || (i) Bipolar Cord, Twin Pin to Wolf Kleppinger, 12' (3.6m), REF 40-1113, QTY 10 || (j) Bipolar Cord, Wolf to Wolf Kleppinger, 12' (3.6m), REF 40-1114, QTY 10 || (k) Bipolar Cord, 28 mm Fixed Pin to Wolf Kleppinger, 12' (3.6m), REF 40-1115-28, QTY 10 || (l) Integrated Irrigation Tubing and Bipolar Cord Set, 12' (3.6m), REF 40-3001R, QTY 10 || (m) Integrated Irrigation Tubing and Bipolar Cord Set, 12' (3.6m), REF 40-3003-R-39, QTY 10 || (n) Bipolar Cord, Twin Pin Connector, 12' (3.6m), REF G-40-1102, QTY 10 || Intended for use in coagulating tissue.
  • Manufacturer
    Olsen Medical

Manufacturer

Olsen Medical
  • Adresse du fabricant
    Olsen Medical, 3230 Commerce Center Pl, Louisville KY 40211-1900
  • Société-mère du fabricant (2017)
    Olsen Medical Llc
  • Source
    USFDA