Events

Rappel de FRAZIER Surgical Suction Instrument, 12 French 50/C

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 Conmed Corporation.

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
    45862
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0561-2008
  • Date de mise en oeuvre de l'événement
    2007-09-12
  • Date de publication de l'événement
    2008-02-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66298
  • 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
    Laparoscope - Product Code GCJ
  • Cause
    Sterility (package integrity) compromised -- frazier and poole suction instruments may have an inadequate seal. the product pouch seal made during assembly of this product, may be incomplete or not present.
  • Action
    URGENT-Device Recall Letters (dated 9/10/07) and FIELD CORRECTIVE ACTION CERTIFICATION forms were sent via Certified Mail to affected customers the week of 9/09/07 (mailed on 9/12/07). The recall letters informed the consignees of the recall due to potentially inadequate seals of the instruments, and instructed them to review their inventory of the instruments checking them for inadequate seals. The letters also instructed the consignees to complete the form and fax it back by 9/21/07. For those consignees that have any of the recalled instruments or may have questions, please contact ConMed Quality Assurance at 1-800-552-0138 ext. 5225 between the hours of 7 am - 6 pm (MST). International customers were notified on 9/18/07. A second recall letter (dated 10/09/07) was sent to non-respondents of the initial mailing. ConMed plans to send a third recall letter to the non-responders during the week of 12/10/07 which addresses sub-recall notifications to the distributors' customers.

Device

FRAZIER Surgical Suction Instrument, 12 French 50/C
  • Modèle / numéro de série
    Product Code: 0033120; All lot codes manufactured between 10/04/06 and 7/31/07 (lots 061004 through 070731). Lot codes on boxes and packaging contain a 6 digit lot code: For example, lot 061004: the first 2 digits represent the year manufactured (06 represents 2006), next 2 digits represent the month (10 represents October), the next 2 digits represent the day of the month (04).
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and Worldwide Distribution
  • Description du dispositif
    FRAZIER Surgical Suction Instrument, 12 French with Control Vent and Obturator, Product Code: 0033120, 50/C. STERILE, EO, Rx ONLY. MANUFACTURED FOR CONMED CORPORATION, 310 Broad Street, Utica, NY 13501
  • Manufacturer
    Conmed Corporation

Manufacturer

Conmed Corporation
  • Adresse du fabricant
    Conmed Corporation, 525 French Road, Utica NY 13502-5945
  • Source
    USFDA