Recall Z-1493-2011 ยท DRX Electrode, Electrocardiograph
ConMed Corporation
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
| Date | Mar 2, 2011 (initiated Sep 23, 2010) |
| Status | Terminated |
| Reason | 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 | 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 A |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K901555 | MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE Medtronic Vascular, Jul 18, 1990 |