Events

Rappel de Device Recall ReNew brand Disposable Scissor and Dissector Tips

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 Microline Surgical, 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
    79435
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1740-2018
  • Date de mise en oeuvre de l'événement
    2017-11-01
  • 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=162314
  • 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
    Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.
  • Action
    Microline Surgical sent an Urgent Medical Device Recall letter dated November 1, 2017. Actions to be taken by the Customer/User: Please locate those products you have, quarantine them, and arrange for their return by contacting Microline Customer Service to receive an RMA number. Alternatively, you may wish to contact your Microline Distributor or Sales Representative to help with this. If you have used some or all of the identified product, please provide the item number, lot number, and the amount used so that we can track the progress of the recall. T To date, we have no evidence to suggest that the sterile barrier provided by the sealed pouches were damaged because of the rework, but are initiating this recall out of an abundance of caution because if a sterile barrier was compromised, there is potential that use of the device could result in an infection. If you experience any adverse events or quality problems with the use of this product, you should report this to FDAs MedWatch Adverse Event Reporting Program and to Microline as soon as possible. All product returned will be replaced at no cost. We regret any inconvenience and encourage you to contact Microline Customer Service at 978- 922-9810 or inf o@m icr olinesur g ical.com. with any further questions. For further questions, please call (978) 867-1758.

Device

Device Recall ReNew brand Disposable Scissor and Dissector Tips
  • Modèle / numéro de série
    Lot Numbers: 70208, 70209, 70210  UDI: 00811099011989
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in the following U.S. states: FL, MA, MI, OH, OK TN, and Netherlands.
  • Description du dispositif
    ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 || The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
  • Manufacturer
    Microline Surgical, Inc.

Manufacturer

Microline Surgical, Inc.
  • Adresse du fabricant
    Microline Surgical, Inc., 50 Dunham Rd, Suite 1500, Beverly MA 01915-1882
  • Société-mère du fabricant (2017)
    HOYA Corp.
  • Source
    USFDA