Class 2 Device Recall Medstorm Adult Radiolucent Electrode

• Date Initiated by Firm: December 17, 2010
• Date Posted: February 18, 2011
• Recall Status: Terminated on July 13, 2011
• Recall Number: Z-1372-2011
• Recall Event ID: 57736
• 510(K)Number: K080421
• Product Classification: Electrode, electrocardiograph, multi-function - Product Code MLN
• Product: 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 cardiac pacemaker and the patients skin. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the respective low power mono-phasic or bi-phasic defibrillator (360 joules maximum) or external pacemaker.
• Code Information: Lot # Y032709-1
• Recalling Firm/ Manufacturer: Heart Sync, Inc; 5643 Plymouth Rd; Ann Arbor MI 48105-9586
• For Additional Information Contact: Stephen Shulman; 800-828-4681
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 send replacement product as soon as they were notified. Complete and return the Recall Return Response Form to the firm in the attached prepaid envelope. For any questions regarding this recall call 734-213-5530.
• Quantity in Commerce: 300
• Distribution: Worldwide Distribution - USA including AK, AZ, CA, FL, IL, KS, LA, MA, ND, NM, OH, TX, WA, WI and WV; and Canada
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MLN and Original Applicant = HEART SYNC LLC