Z-1669-2013Class II

Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx...

Name: Z-1669-2013 Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx...
Creator: Cardio Medical Products
Published: 2013-04-26
License: https://open.fda.gov/license/

Cardio Medical Products, Inc. / initiated 2013-04-26 / Terminated / root cause: manufacturing process

FDA source

Cardio Medical Products began a recall of Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio... on 2013-04-26. FDA classified it as Class II and gives the reason as "Covidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire which may affect Cardio Medical Products Inc. defibrillator electrodes Model Number O101". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1669-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-26
Posted: 2013-07-08
Terminated: 2016-08-15
Recalling firm: Cardio Medical Products, Inc.
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
Product code: LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
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.
Root cause tag: manufacturing process
FDA root cause: 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
Product codes and lots: 510 K K103159 Part number O101 Lot numbers Y111412-2 Y111912-17 Y020613-03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1669-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1669-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-17	2013-07-08

Product code LDD

K103159Class IICardio Med Model A102, H104, O101, P103, and Z100Cardio Medical Products, Inc. / cleared 2011-01-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)