Events

Recall of Neotrode, Softrade, TruLink

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
    57827
  • Event Risk Class
    Class 2
  • Event Number
    Z-1493-2011
  • Event Initiated Date
    2010-09-23
  • Event Date Posted
    2011-03-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97513
  • 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
    ecg electrode - Product Code DRX
  • Reason
    Poor signal or loss of signal. certain recalled devices have a loose wire attachment that may lead to intermittent or poor signal quality.
  • Action
    ConMed Corporation distributed an Urgent Device Recall notification letter on Tru-Link ECG Electrode (Neonatal Pre-wired) dated September 23, 2010. ConMed Corp. has advised to cease the use of the devices immediately and conducted a recall to the user level. Direct consignees were asked to contact sub-accounts if recalled devices were further distributed and notified them of such recall. Recalled devices were to return to ConMed Corp. at 525 French Road, Utica, NY 13502 with completed Attachment II to indicate the amount returned. Customers with no recalled devices were asked to fill out Attachment II and faxed to 315-624-3225. Questions can be directed to Ms. Patricia Cotter, ConMed Recall Coordinator at 315-624-3237 or fax to 315-624-3225 or email to neorecall@conmed.com.

Device

Neotrode, Softrade, TruLink
  • Model / Serial
    Neotrode, Wire Attached (Catalog Number: 1731-003) Lot Code: 0904014 thru 1008134; Neotrode II, Wire Attached (Catalog Number: 1741-003) Lot Code: 0904014 thru 1008114; Softrace Limb Band (Catalog Number: 2310-003) Lot Code: 0904014 thru 1008274; Softrace Neonatal, Wire Attached (Catalog Number: 2321-003) Lot Code: 0904014 thru 1007234; Softrace Pediatric, Wire Attached (Catalog Number: 2331-003) Lot Code: 0904014 thru 1007214; and TRU-LINK ECG Electrodes (Neonatal Pre-Wired) (Catalog Number: 685-0037-00) Lot Code: 0904014 thru 1007064
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution, including USA, Dubai, Ecuador, Egypt, Germany, Holland, Indonesia, Israel, Italy, Jamaica, Kenya, Korea, Lithuania, Malaysia, Mexico, New Zealand, Norway, Qatar, Saudi Arabia, Singapore, South Africa, Sweden, Switzerland, US Virgin Islands, Canada and Belgium.
  • Product Description
    Neotrode Wire Attached, Catalog Number: 1731-003; Neotrode II Wire Attached, Catalog Number: 1741-003; Softrace Neonatal Wire Attached, Catalog Number: 2321-003; Softrace Pediatric Wire Attached, Catalog Number: 2331-003; Softrace Limb Band, Catalog Number: 2310-003; TRU-LINK ECG Electrode (Neonatal Pre-Wired), Catalog Number: 685-0037-00; for use with electrocardiographic monitoring equipment to detect neonatal/pediatric heart action voltages.
  • Manufacturer
    ConMed Corporation

Manufacturer

ConMed Corporation
  • Manufacturer Address
    ConMed Corporation, 525 French Road, Utica NY 13502
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    USFDA