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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Product Detail

Product Description Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible defibrillation/cardioversion/pacing/ECG Monitoring electrodes. Used in connection with a defibrillator to deliver an electrical current (shock) to the patient's heart during cardiac emergencies.
Recall Number Z-1435-2013
Classification Class II
Code Info Part Number: D304 and lot numbers:Y100112-02, Y102212-03, Y121312-18, Y012413-02, Y022013-01, Y032113-01
Product Distributed Qty 17180 units for all part numbers
Reason For Recall On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100-Physio Electrodes. There were reports of equipment damage due to misalignment from tooling installed in August 2012. The result of this damage could render the device incapable of delivering the appropriate energy or shock to the patient.

Event Detail

Event Id 65085
Product Type Devices
Status Ongoing
Recalling Firm Heart Sync, Inc
City Ann Arbor
State MI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-26
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Worldwide Distribution - USA including AL, GA, MI, MN, NC, ND, OH, PA, SD, VA, VT, OH, TX, MA, and Internationally to Korea.