Z-1431-2010

Unilect ECG Electrodes Unomedical, McAllen Texas

Name: Z-1431-2010 Unilect ECG Electrodes Unomedical, McAllen Texas
Creator: ConvaTec
Published: 2010-03-11
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2010-03-11 / Terminated / root cause: manufacturing process

FDA source

ConvaTec began a recall of Unilect ECG Electrodes Unomedical, McAllen Texas. Intended use:Cardiac monitoring on 2010-03-11. The reason FDA records is "In an emergency situation where defibrillation is necessary and electrodes are already in use, the electrodes may malfunction and incorrectly report lack of cardiac activity". 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-1431-2010
Status: Terminated
Initiated: 2010-03-11
Posted: 2010-04-22
Terminated: 2011-06-21
Recalling firm: ConvaTec Limited
Product: Unilect ECG Electrodes Unomedical, McAllen Texas. Intended use:Cardiac monitoring
Product code: DRX Electrode, Electrocardiograph
Reason for recall: In an emergency situation where defibrillation is necessary and electrodes are already in use, the electrodes may malfunction and incorrectly report lack of cardiac activity.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The one distributor was notified personally on March 9, 2010. All remaining stock was put on hold, and a "URGENT : MEDICAL DEVICE RECALL" letter dated March 11, 2010, was sent to customers. The letter describes the product, problem and action to be taken by customers. All customers were asked to immediately stop distributing and quarantine all recalled lots. The customers were ask to perform a count of recalled product currently in inventory, complete and return the Recall Response Form even if no recalled product is in inventory, send a copy of response to distributor in order to receive reimbursement, and to call 1-800-582-6514 for instructions on how to return the recalled product. If you have any questions, please contact Convatec at 908-904-2425.
Quantity in commerce: 567,000 units
Distribution: Nationwide distribution: CA
Product codes and lots: Model Number 4560M; Lots: 706268, 708152, 709705, 711967, 713648, 713977, 714391, 714392, 714685, 714687.

Product code DRX

K990113Class IIDisposable ECG Monitoring Electrodes, Models 4500,4530, 4533, 4539, 4540, and 4560Maersk Medical A/S / cleared 1999-12-06

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)