—#97513

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.

FDA product code: DRX — Electrode, Electrocardiograph
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K901555
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: ConMed Corporation
Address: 525 French Road, Utica, New York 13502

Distribution

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.

Timeline

Recall initiated: 2010-09-23
Posted by FDA: 2011-03-02
Terminated: 2014-10-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #97513. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.