Events

Recall of FRAZIER Atraumatic Soft Tip Surgical Suction Instrument, 10 French 20/C

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Conmed Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    45862
  • Event Risk Class
    Class 2
  • Event Number
    Z-0558-2008
  • Event Initiated Date
    2007-09-12
  • Event Date Posted
    2008-02-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66295
  • Notes / Alerts
    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.
  • Extra notes in the data
    Laparoscope - Product Code GCJ
  • Reason
    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 Atraumatic Soft Tip Surgical Suction Instrument, 10 French 20/C
  • Model / Serial
    Product Code: 0031100; 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).
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Worldwide Distribution
  • Product Description
    FRAZIER Atraumatic Soft Tip Surgical Suction Instrument with Control Vent and Obturator, 10 French, Product Code: 0031100, 20/C. STERILE, EO, Rx ONLY. MANUFACTURED FOR CONMED CORPORATION, 310 Broad Street, Utica, NY 13501
  • Manufacturer
    Conmed Corporation

Manufacturer

Conmed Corporation
  • Manufacturer Address
    Conmed Corporation, 525 French Road, Utica NY 13502-5945
  • Source
    USFDA