Recall Z-1951-2011 ยท MLN Electrode, Electrocardiograph, Multi-Function
Heart Sync, Inc
Heart Sync Adult Radiolucent Electrode -Physio Control, Part T100LO-PHYSIO. Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only.
| Date | Apr 12, 2011 (initiated Dec 5, 2008) |
| Status | Terminated |
| Reason | The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonstration. |
| Root cause | Equipment maintenance |
| Action | The firm sent a recall notice to their distributors on 12/3/2008 asking them to quarantine product and return it to HeartSync. The letter stated that customers' current inventory would be exchanged for new product. Customers were to call 1-800-828-4681 to provide the necessary information. |
| Quantity | 50 (5 cases of 10 each) |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080421 | HEART SYNC, MODELS C-100 AND T-100 Heart Sync, LLC, Feb 29, 2008 |