Recall Z-1372-2011 ยท MLN Electrode, Electrocardiograph, Multi-Function
Heart Sync, Inc
Medstorm Adult Radiolucent Zoll Medical (Part # 16381, HeartSync, Ann Arbor, MI. The Adult Radiolucent Multifunction Tin Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous cardia
| Date | Feb 18, 2011 (initiated Dec 17, 2010) |
| Status | Terminated |
| Reason | The seal on the electrode pouch may be open, exposing the electrode to the outside environment. The package does have a caution statement that states, " Do not open package until immediately prior to using electrodes. and Electrodes may dry out when removed from packaging and exposed to air. |
| Root cause | Packaging |
| Action | Heart Sync, Inc sent an URGENT MEDICAL DEVICE RECALL letter dated December 23, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Examine their inventory and quarantine product that was subject to the recall that was not sealed properly. Contact any customers if they further distributed the product and notify them at once of this product recall. Contact the firm if they had any unused product. The firm would issue a UPS Call Tag to have the product returned to them and the firm would s |
| Quantity | 300 |
| Distribution | Worldwide Distribution - USA including AK, AZ, CA, FL, IL, KS, LA, MA, ND, NM, OH, TX, WA, WI and WV; and Canada |
| 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 |