Z-2383-2010

3M Red Dot Monitoring Electrode, Catalog #2560 & Novaplus Universal Monitoring Electrode #V2560, used for ECG...

Name: Z-2383-2010 3M Red Dot Monitoring Electrode, Catalog #2560 & Novaplus Universal Monitoring Electrode #V2560, used for ECG...
Creator: 3M Company / Medical Division
Published: 2010-07-27
License: https://open.fda.gov/license/

3M Company / initiated 2010-07-27 / Terminated / root cause: manufacturing process

FDA source

3M Company / Medical Division began a recall of 3M Red Dot Monitoring Electrode, Catalog #2560 & Novaplus Universal Monitoring Electrode #V2560, used for ECG monitoring on 2010-07-27. The reason FDA records is "The sensing element of the 3M Red Dot Monitoring Electrode, Catalog # 2560 and Novaplus Universal Monitoring Electrode #V2560 may have corrosion. In an emergency situation where defibrillation is necessary and...". 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-2383-2010
Status: Terminated
Initiated: 2010-07-27
Posted: 2010-09-07
Terminated: 2012-04-19
Recalling firm: 3M Company
Product: 3M Red Dot Monitoring Electrode, Catalog #2560 & Novaplus Universal Monitoring Electrode #V2560, used for ECG monitoring.
Product code: DRX Electrode, Electrocardiograph
Reason for recall: The sensing element of the 3M Red Dot Monitoring Electrode, Catalog # 2560 and Novaplus Universal Monitoring Electrode #V2560 may have corrosion. In an emergency situation where defibrillation is necessary and electrodes are already in use, the electrodes may malfunction and provide a delayed or no trace response.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 3M sent an "Urgent Medical Device Recall" letters and a "Distributor Product Recall Form" dated July 29, 2010 to customers and distributors of the 3M and Novaplus electrodes. The letters described the 3M Red Dot and Novaplus Universal products, problems and actions to be taken by customers. Customers were instructed to examine their inventory and quarantine the affected lots pending return to the firm. After completing and returning the enclosed Customer Product Recall Form to 3M, customers will be issued a Return Authorization Number and provided with instructions for return of the affected devices. Distributors were instructed to notify customers to the end user level and have them return affected lots to the distributor for forwarding to 3M, or forward the customer letter to end-users to instruct them on how to contact 3M for recovery of the device. The 3M Customer Helpline can be contacted at: 1-800-228-3957.
Quantity in commerce: 11,063 cases (20 pouches/case, 50 electrodes/pouch)
Distribution: Nationwide Distribution: States of CA, FL, IL, KS, KY, MI, MO, NE, NJ, NY, OH, PA, RI, SD, TN, VA, and WI.
Product codes and lots: 2560 LOT #'S: 2012-06 CX, 2012-06 CY, 2012-06 CZ, 2012-06 DA, 2012-06 DB, 2012-05 CN, 2012-05 CM, 2012-05 CK, 2012-05 CJ, 2012-05 CI, 2012-05 CH,2012-05 CG, 2012-05 CF, 2012-05 CE, 2012-05 CD, and 2012-05 CC. V2560 NOVATION PRIVATE LABEL LOT: 2012-05 CL.

Product code DRX

K970796Class II3M Red Dot 2560 & 2570 Monitoring Electrodes3M Healthcare / cleared 1997-04-09

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)