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U.S. Department of Health and Human Services

Class 2 Device Recall Cardio Medical Products Inc.

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  Class 2 Device Recall Cardio Medical Products Inc. see related information
Date Initiated by Firm April 26, 2013
Date Posted July 08, 2013
Recall Status1 Terminated 3 on August 15, 2016
Recall Number Z-1669-2013
Recall Event ID 65462
510(K)Number K103159  
Product Classification Dc-defibrillator, low-energy, (including paddles) - Product Code LDD
Product Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only
Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866
www.cardiomedicalproducts.com
(800) 227-3633 (973) 586-9624 FAX

Defibrillator
Code Information 510 K K103159  Part number O101  Lot numbers Y111412-2 Y111912-17 Y020613-03 
Recalling Firm/
Manufacturer		 Cardio Medical Products
385 Franklin Ave
Rockaway NJ 07866-4037
Manufacturer Reason
for Recall		 Covidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire which may affect Cardio Medical Products Inc. defibrillator electrodes Model Number O101.
FDA Determined
Cause 2		 Process control
Action Cardio Medical Products, Inc. issued an Urgent Medical Device Recall letter dated April 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory and segregate any product with the affected lot numbers and return affected product according to the instructions for product credit by contacting the Customer Service group at 1-800-962-9888, option 1, then option 2, and reference the recall letter to request a Return Goods Authorizing (RGA). Customers were instructed to complete the enclosed Verification Form and return it to Covidien by fax to 800-895-6140, even if they did not have any of the affected lots. Customers were also instructed to report any issues to the Quality Assurance Group to ensure proper device reporting procedures are followed. Customers with questions were instructed to call 1-800-962-9888, option 8, then ext 2500. For questions regarding this recall call 973-586-9500.
Quantity in Commerce 657 units
Distribution Nationwide Distribution
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 = LDD and Original Applicant = CARDIO MEDICAL PRODUCTS, INC.
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