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U.S. Department of Health and Human Services

Class 2 Device Recall MicrV Alternans Sensors

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  Class 2 Device Recall MicrV Alternans Sensors see related information
Date Initiated by Firm April 29, 2010
Date Posted June 07, 2010
Recall Status1 Terminated 3 on September 20, 2011
Recall Number Z-1776-2010
Recall Event ID 55505
510(K)Number K002230  
Product Classification electrode, electrocardiograph - Product Code DRX
Product The Alternans Sensor Kit Assembly is a sealed kit that contains the components necessary for conducting a Microvolt Twave Alternans test.
Code Information Alternans Sensor Kits Kit Dispenser Box Lot # 550312 Lot # 5229 Lot # 700104 Lot # 5734 Lot # 700362 Lot # 6343 Lot # 700383 Lot # 6433 Lot # 700585 Lot # 6853 Lot # 700589 Lot# 6966 Lot # 700649 Lot # 7178
Recalling Firm/
Manufacturer		 Cambridge Heart, Inc.
100 Ames Pond Dr
Tewksbury MA 01876-1293
For Additional Information Contact Kevin Bernier
978-654-7643
Manufacturer Reason
for Recall		 Some kits contained a component with expiration date prior to the date of expiry on the outside of the kit. The user receives feedback of potential unreliable results at several stages during the test process, so any risk of unreliable results is low.
FDA Determined
Cause 2		 Process control
Action The Alternate Sensor Kit Assembly P/N 203270209 may contain a pouch of standard ECG electrodes with an expiry date which is earlier than the expiration date on the outside label of the kit. All customers were sent a letter dated April 23, 2010 with information that included instructions for returning the kits. Questions are directed to the company's Quality Manager and Recall Coordinator at phone number 978-654-7625.
Quantity in Commerce 2740
Distribution Nationwide
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 = DRX and Original Applicant = CAMBRIDGE HEART, INC.
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