Z-1493-2011

Neotrode Wire Attached, Catalog Number: 1731-003; Neotrode II Wire Attached, Catalog Number: 1741-003...

Name: Z-1493-2011 Neotrode Wire Attached, Catalog Number: 1731-003; Neotrode II Wire Attached, Catalog Number: 1741-003...
Creator: ConMed Corporation
Published: 2010-09-23
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2010-09-23 / Terminated / root cause: manufacturing process

FDA source

ConMed Corporation began a recall of Neotrode Wire Attached, Catalog Number: 1731-003; Neotrode II Wire Attached, Catalog Number: 1741-003; Softrace Neonatal Wire Attached, Catalog Number... on 2010-09-23. The reason FDA records is "Poor signal or loss of signal. Certain recalled devices have a loose wire attachment that may lead to intermittent or poor signal quality". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1493-2011
Status: Terminated
Initiated: 2010-09-23
Posted: 2011-03-02
Terminated: 2014-10-28
Recalling firm: ConMed Corporation
Product: 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.
Product code: DRX Electrode, Electrocardiograph
Reason for recall: Poor signal or loss of signal. Certain recalled devices have a loose wire attachment that may lead to intermittent or poor signal quality.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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 [email protected].
Quantity in commerce: 9,009,000 Pediatric/Neonatal ECG Electrodes with Attached Wire
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 codes and lots: 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 code DRX

K901555Class IIModel 1730 Neotrode with Attached LeadwireMedtronic Vascular / cleared 1990-07-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)