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.
FDA Recall Z-1493-2011 · Posted 2011-03-02
Recalling FirmConMed Corporation
Recall StatusTerminated
Product CodeDRX
Date Initiated2010-09-23
Date Terminated2014-10-28
Product Quantity9,009,000 Pediatric/Neonatal ECG Electrodes with Attached Wire
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.
Firm 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].
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.